[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinson-disease-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinson-disease-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,52,82,105,134,160,191,216,241,264,287,315,343,366,385,411,444,467,479,506,533,558,580,603,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100053255","phase-3-intestinal-levodopa--entacapone-therapy-lecigon-to-counteract-dopaminergic-desensitization-and-neuropsychiatric-complications-in-parkinsons-disease-100053255",false,"NCT07151378","Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease","INITIATE-LECIG","Inclusion Criteria:\n\n* Understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures. 2. Able to adhere to the study visit schedule and other protocol requirements. 3. Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during the study (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner2, sexual abstinence3).\n\n  1. For the purpose of this document, a female is considered of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n  2. Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success\n  3. In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. 4. All subjects must agree not to share medication. 5. Diagnosis of Idiopathic PD, inclusive of familial PD and genetic forms of L-Dopa responsive PD Age 18 - 75 years 7. Age at Parkinson's disease onset before 65 years 8. Disease duration ≥ 5 years 9. Oral medication constant for four weeks prior to baseline visit 10. Oral treatment with L-Dopa and non-ergot dopamine agonist(s) (any preparation, any dosage) 11. Presence of dopaminergic motor fluctuations based on patient history 12. Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history 13. Presence of behavioural hyperdopaminergic syndrome including clinically relevant neuropsychiatric behavioural abnormalities according Ardouin Behavioural Scale Section 1, hypomanic symptoms, psychosis + Section 4 hyperdopaminergic behaviours (score ≥ 3), eventually further accompanied by impulse control disorders, a\u002Fo dopamine dysregulation, syndrome, a\u002Fo hallucination - psychosis spectrum; in case symptoms of the hallucination\u002Fpsychosis or hypomania-mania spectrum are present, retained insight is mandatory at the time of study enrolment\n\nExclusion Criteria:\n\n* 1.Women during pregnancy and lactation. 2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 3. Participation in other clinical trials or observation period of competing trials over the past three months 4. Patients suffering from cognitive impairment (MoCA \\\u003C 21) will be excluded for the major reason to obtain valid Ardouin assessments that will be hampered in case cognitive impairment (and therefore insight) is too severe 5. Acute paranoid psychosis without retained insight (however impulse control disorder or dopamine dysregulation syndrome are not an exclusion criterion; illusions or (pseudo)-hallucinations are not an exclusion criterion as long as there is no endangerment of the patients themselves or other persons owing to clinical judgement; patients may be eligible after remission of psychosis\u002Fsuicidality) 6. Severe depression according to ICD-10 criteria; however, affective fluctuations with intermittent depressive symptoms (reversed by dopaminergic medication) are not an exclusion criterion 7. Active suicidality without self-distancing (however, suicidal ideation\u002Fthoughts or passive wishes of being dead are not an exclusion criterion as long as the patient is credibly distancing from it). 8. General contraindications for intestinal L-Dopa therapy (according to Lecigon® Fachinformation) 9. Gastrointestinal contraindications against PEG-J tube placement 10. Tremor-dominant PD without dopaminergic response fluctuationt Pre-existing device assisted therapy (DAT) immediately before study enrolment including with DBS, LCIG\u002FLECIG, or subcutaneous therapy with apomorphine or foslevodopa; if patient terminated pre-existing subcutaneous therapy, the patient will be eligible after having received oral dopamine replacement therapy for at least 3 months 12. Malignancy in a non-remitted stage","ALL","18 Years","75 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the \"hyperdopaminergic symptoms\" corresponding to section 3 of the \"Ardouin Behavioural Scale\" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.",[28],"PARKINSON DISEASE (Disorder)",[30,31,32,33,34,35,36,37,38],"LECIG","device assisted therapy","motor and non-motor fluctuations","dopaminergic complications","impulse control disorder","levodopa seeking","dopamine dysregulation syndrom","dopamine agonist","intestinal levodopa","RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":43},"2025-10-27",{"date":47,"type":22},"2030-09-22",{"name":49,"class":50},"University Hospital Tuebingen","OTHER",7,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100053516","swallowfit-study-in-parkinsons-disease-100053516","NCT07356414","SwallowFIT Study in Parkinson's Disease","\"SwallowFit,\" an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.","Inclusion Criteria:\n\n1. Adult S-VWP between \\>35-90 years of age\n2. Diagnosis of Idiopathic Parkinson's Disease \\[IDP\\] (either or suspected, tremor-predominant or rigid predominant)\n3. Disability level of Hoehn \\& Yahr stages II-III as indicated in their most recent neurological evaluation\n4. Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale \\[MDS-UPDRS\\]-\n5. ADL swallowing item \\>0, or Mann Assessment of Swallowing scale \\[MASA\\] score ≤185.\n6. Able to consume oral nutrition \\[Functional Oral Intake Score ≤ 6\\]\n7. Ambulatory\n8. No change of medication for at least 4 weeks before study inclusion\n\nExclusion Criteria:\n\n1. Classified as Hoehn and Yahr stages IV\n2. Unable to follow 2 step commands\n3. History of other neurological disease potentially causing dysphagia\n4. Dementia (MMSE\\\u003C20; Montreal cognitive assessment (MoCA) ≤ 20)\n5. Severe depression (BDI\\>19)\n6. Severe dyskinesia of head and neck (resulting in problems with MBSS recording)\n7. Severe documented Gastrointestinal disease\n8. History of Gastro-esophageal surgery\n9. History of Head or neck cancer with swallowing impairment or surgical intervention\n10. History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.\n11. Untreated hypertension\n12. Heart disease requiring restricted activity and medical intervention\n13. Speech therapy intervention for swallowing within the past three months\n14. Women who are pregnant, nursing, or who plan to become pregnant during the study","35 Years","90 Years",{"count":62,"type":22},80,[64],"NA","The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.\n\nThe aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.\n\nPatients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.\n\nPatients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.",[28],[68,69,70,71],"Swallowing","US Service members","Veterans","SwallowFIT","NOT_YET_RECRUITING","2026-07-09",{"date":42,"type":43},{"date":76,"type":22},"2026-08-30",{"date":78,"type":22},"2028-06-29",{"name":80,"class":50},"The University of Texas Health Science Center at San Antonio",1,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":81},"100645144","integrated-digital-and-neurogenic-exosome-biomarkers-for-early-diagnosis-of-parkinsons-disease-development-and-application-100645144","NCT07679256","Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application","Inclusion Criteria:\n\n* 1\\. Healthy Control Group\n\n  1. No severe mental illness;\n  2. Mini-Mental State Examination (MMSE) score \\>24 points; 2. Prodromal PD Group\n\n  \u003C!-- -->\n\n  1. Meets the diagnostic criteria for rapid eye movement sleep behavior disorder;\n  2. Has no severe mental disorders;\n  3. Mini-Mental State Examination (MMSE) score is greater than 24 points. 3. Early PD Group\n\n  (1) Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria ; (3) Hoehn-Yahr (H-Y) stage \\\u003C=2.0 during off-medication periods; (4) Mini-Mental State Examination (MMSE) score \\>24 points;\n\nExclusion Criteria:\n\n1. Presence of mental, cognitive, or psychological disorders, unable to sign informed consent;\n2. Presence of other diseases affecting walking distance, such as lower limb joint lesions, spinal lesions, neurological disorders, or severe cardiopulmonary diseases;\n3. Presence of intracranial structural changes, cerebrovascular disease, or other neurological disorders;\n4. Presence of tumors, severe liver or kidney dysfunction (indicators exceeding three times the normal value), or other conditions that significantly impact health;\n5. Claustrophobia or presence of implants affecting MRI scanning.",true,"40 Years","80 Years",{"count":92,"type":22},700,"OBSERVATIONAL","Based on the high-quality Parkinson's disease cohort population and biological sample database in the early stage of the team, multi-dimensional intelligent wearable device technology and machine learning were used to screen and classify digital biomarkers in the prodromal PD cohort, early PD cohort and healthy population cohort. Using peptide nanoprobes, metabolomics and Simoa technology to find the pathological molecular biomarkers of high-purity blood neurogenic exosomes in the prodromal stage of PD cohort, early PD cohort and healthy population cohort, and conduct classification and combination study. The association analysis was used to explore the specific internal relationship between digital biomarkers and neurogenic exosome molecular biomarkers, to explore the potential relationship between the two types of biomarkers, and to further apply machine learning methods to establish a fusion model for early diagnosis of PD including markers related to digital phenotype and pathological molecular mechanism, and to verify it clinically. The research results of this project are expected to bring new strategies for the early diagnosis of PD biomarkers, provide theoretical support for clinical transformation, and have important clinical significance for achieving the goal of early diagnosis and early treatment.",[28],"2026-06-25",{"date":98,"type":43},"2026-07-01",{"date":100,"type":43},"2024-01-01",{"date":102,"type":22},"2027-12-31",{"name":104,"class":50},"Fujian Medical University Union Hospital",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":60,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":81},"100634031","treatment-of-cognitive-and-sensorimotor-deficits-in-parkinsons-disease-with-high-definition-transcranial-direct-current-stimulation-100634031","NCT07534397","Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* Diagnosed with PD having a verbal fluency deficit based on neuropsychological test (T-score \\\u003C 40 or a T-score \\\u003C-1.0 SD below the average T-score): Semantic Object Retrieval Test (SORT), COWAT (both letter and category fluency), Boston Naming Test (BNT), Rey Auditory Verbal Learning Test (RAVLT)\n* 50 - 90 years old\n* Capable of understanding and signing an informed consent (able to answer consent comprehension questions)\n* Fluent in speaking and reading English\n\nExclusion Criteria:\n\nA potentially study-confounding, tDCS-contraindicated, or EEG-contraindicated psychological, neuropsychiatric, neurological, or other medical issues:\n\n* Montreal Cognitve Assessment (MOCA) score \\\u003C23, unless an accompanying study partner\u002Fcaregiver is with them and we can obtain the written consent of both the participant and the participant's accompanying study partner\u002Fcaregiver (i.e., the participant's spouse, adult child, parent, or adult sibling);\n* history of seizures;\n* unexplained episodes of loss of consciousness (as these may be related to brain alterations or epilepsy);\n* suffering from severe or frequent headaches;\n* unstable or uncontrolled neuropsychiatric illness;\n* severe traumatic brain injury (based on the Ohio State TBI Identification; Method);\n* brain tumor; stroke; present drug abuse\u002Fmisuse;\n* brain tumor;\n* serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;\n* Huntington's disease;\n* stroke;\n* cranial implants or skull defects that affect tDCS administration;\n* implanted brain medical devices, including, deep brain stimulators (DBS);\n* implanted pacemakers;\n* any electrically, magnetically, or mechanically activated implants;\n* cardiac, neural, or medication implants;\n* vascular clips or other electrically sensitive support systems in the brain;\n* damaged skin at the sites of stimulation (the device should only be used on healthy, intact skin, as wounds may alter resistance to current);\n* skin conditions such as dermatitis, psoriasis, or eczema;\n* pregnant women;\n* diagnosis of just dysarthria;\n\nUse of medications that interact with or potentially interact with tDCS or EEG effects:\n\n* anti-convulsants;\n* carbamazepine;\n* sulpiride;\n* pergolide;\n* lorazepam;\n* rivastigmine;\n* dextromethorphan;\n* D-cycloserine;\n* flunarizine;\n* ropinirole;\n* citalopram;\n* stimulants;\n\nAdditionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.","50 Years",{"count":113,"type":22},20,[64],"The purpose of this research study is to examine the effects of transcranial Direct Current Stimulation (tDCS) on verbal retrieval and cognition and sensorimotor control and to determine if tDCS can be used as a way to improve retrieval, sensory, and motor abilities in individuals with Parkinson's disease (PD).",[28],[118,119,120,121,122,123,124],"transcranial direct current stimulation (tDCS)","Parkinson's Disease","electroencephalography (EEG)","presupplementary motor area (preSMA)","verbal memory","speech sequencing","motor sequencing","2026-06-24",{"date":127,"type":43},"2026-06-26",{"date":129,"type":22},"2026-08-01",{"date":131,"type":22},"2027-10-31",{"name":133,"class":50},"The University of Texas at Dallas",{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":142,"maxAge":19,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":81},"100609501","phase-2-prescriptive-infusion-algorithm-pia-100609501","NCT07215403","Prescriptive Infusion Algorithm (PIA)","Open-Label, Multi-Stage Study to Optimize the Intraputaminal Administration of AB-1005 Using a Prescriptive Infusion Algorithm (PIA)","PIA","Inclusion Criteria:\n\n* Participant must be 45 to 75 years of age inclusive, at the time of signing the informed consent.\n* \\>10 years since diagnosis of PD (at time of consenting \u002F Screening Visit 1)\n* Presence of bradykinesia plus any of the following:\n* Rigidity\n* Resting tremor\n* Postural instability\n* Modified Hoehn and Yahr stage III-IV in the practically defined OFF state\n* Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score \\>40 in the practically defined OFF state\n* Stable anti-PD medication regimen for at least 4 weeks prior to Screening Visit 1 and through Baseline Visit\n* ≥30% reduction in MDS-UPDRS Part III following a levodopa challenge\n* Must agree to use barrier method protection when engaging in intercourse\u002Fsexual activity with another person for at least 3 months post-dosing.\n* Male participants must refrain from donating sperm for at least 3 months post-dosing.\n* Female participants cannot be pregnant or breastfeeding at the time of screening. A woman of childbearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at the required assessments\n* Provision of signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Provision of signed consent to also participate in LTFU study ASK-PD0-CS002\n\nExclusion Criteria:\n\n* Evidence of secondary or atypical parkinsonism (as determined by the neurologist)\n* Presence or history of psychosis or impulse control disorder (as determined by the neurologist)\n* Presence or history (within 2 years prior to screening) of substance use disorder (including alcohol) as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (or in the judgment of the neurologist)\n* Presence of untreated or sub optimally treated depression (Beck Depression Inventory \\[BDI\\]-II score ≥20)\n* Current suicidal ideation as indicated by positive response to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C SSRS), or any history of a suicide attempt\n* Clinically significant cognitive impairment (Montreal Cognitive Assessment \\[MoCA\\] score \\\u003C25)\n* Presence or history of malignancy other than treated cutaneous squamous or basal cell carcinomas\n* Presence of clinically active infection, including acute or chronic scalp infection\n* Known contraindications to MRI\n* Presence or history of significant cerebrovascular or cardiovascular disease, including:\n* Stroke, transient ischemic attack, or other suspected cerebrovascular accident within 1 year prior to screening\n* Unstable angina pectoris or myocardial infarction within 1 year prior to screening\n* Revascularization procedure(s) within 1 year prior to screening\n* Poorly controlled hypertension, poorly controlled diabetes mellitus or prediabetes mellitus with known significant microvascular injury, or other significant cardiovascular history or risk factor\n* Known history of complications of anesthesia including difficult airway management and\u002For difficult endotracheal intubation, malignant hyperthermia, or other related issues that would compromise participant safety during general anesthesia (as determined by the anesthesiologist)\n* Inability to identify a safe trajectory to each putamen via an occipitoparietal entry point, or known contraindications to brain surgery in prone position (as determined by the neurosurgeon)\n* Known allergy or sensitivity to ingredients in the intervention formulation and\u002For to gadolinium-based contrast agents\n* Concurrent use of percutaneous levodopa\u002Fcarbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump\n* History of brain surgery (including deep brain stimulation \\[DBS\\] or focused ultrasound)\n* Chronic immunosuppressive therapy\n* History of prior cell or gene therapy\n* Participation in other interventional clinical trials within 12 weeks prior to screening or unwilling to refrain from starting new investigational agents throughout the course of the study\n* Laboratory values at screening:\n* Platelets ≤100,000\u002Fmm3\n* PT \\>15 s, aPTT \\>40 s, and\u002For INR \\>1.3\n* Absolute neutrophil count (ANC) ≤1500\u002Fmm3\n* Hemoglobin ≤10.0 g\u002FdL\n* Aspartate aminotransferase or alanine aminotransferase ≥2.5 times the upper limit of normal\n* Total bilirubin ≥2.5 mg\u002FdL\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2\n* HbA1C ≥8%\n* Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments (during LTFU study ASK-PD0-CS002)\n* Unwilling to defer any vaccination from screening through 1 month after surgery\n* Any significant issue raised by the neurologist, neurosurgeon, or anesthesiologist that may make a participant unsuitable for the study","45 Years",{"count":144,"type":22},18,[146],"PHASE2","This study is being done to test a new way of delivering AB-1005 into the brain. The goal is to make the procedure easier and quicker to perform, while providing similar amounts of drug to the part of the brain that needs treatment.\n\nTechnical (Stage 0) To test if the new delivery method (prefrontal surgical approach) can consistently deliver AB-1005 to the putamen using MRI monitoring.\n\nTechnical (Stage 1) To test if the new delivery method (PIA-based infusion) can consistently deliver AB-1005 to the putamen using brain imaging by MRI.\n\nTechnical (Stage 2) To confirm the new delivery method works without brain imaging by MRI, using standard operating room tools including brain imaging by CT.\n\nSafety (Stage 1 and 2) To assess the safety and tolerability of the new delivery method for AB-1005 up to 6 months after surgery",[28],[150,151],"PD","Parkinsons Disease",{"date":127,"type":43},{"date":154,"type":22},"2026-07-15",{"date":156,"type":22},"2028-03-01",{"name":158,"class":159},"AskBio Inc","INDUSTRY",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":178,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100641553","cognitive-based-balance-rehabilitation-in-parkinsons-disease-virtual-reality-vs-dual-task-100641553","NCT07660978","Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task","Effects of Cognitive-Based Balance Rehabilitation on Balance, Gait and Cognitive Functions in Parkinson's Disease Patients: Comparison of Virtual Reality and Dual Task","Inclusion Criteria:\n\n* Diagnosed with Parkinson's Disease by a neurologist.\n* Hoehn \\& Yahr Stage I-III.\n* Aged between 40-80 years.\n* Literate and capable of performing basic mathematical calculations.\n* Montreal Cognitive Assessment≥21\n* Stable pharmacological treatment.\n* Physician's approval for exercise participation.\n\nExclusion Criteria:\n\n* Currently participating in another exercise or drug trial.\n* Presence of any additional neurological disorders.\n* Significant musculoskeletal disorders, arthritis, or cardiovascular disease.\n* Uncontrolled epilepsy or severe orthostatic hypotension.\n* Engaged in regular moderate-intensity exercise more than once a week in the last 6 months.",{"count":168,"type":22},34,[64],"This prospective, randomized, single-blind, controlled clinical trial aims to evaluate and compare the efficacy of cognitive-based balance rehabilitation delivered via immersive Virtual Reality (VR) versus traditional Dual-Task Training (DTT) on balance, gait, cognitive functions, and quality of life in patients with Parkinson's Disease (PD). Postural instability and cognitive decline are hallmark features of progressive PD that significantly elevate fall risks and compromise daily independence, yet conventional pharmacological therapies offer limited effectiveness in restoring complex postural control. Given that motor and cognitive processes are intrinsically linked, this study addresses a critical gap in neurorehabilitation by investigating two contemporary modalities designed to challenge these systems simultaneously. A total of 34 participants diagnosed with PD (aged 40-80 years, Hoehn and Yahr stages I-III) will be randomly allocated to either the Dual-Task Group (DTG), receiving structured therapeutic exercises integrated with sequential cognitive tasks, or the Virtual Reality Group (VRG), engaging in an immersive balance program utilizing the Oculus Quest 2® headset with the FIT-XR application. Both groups will undergo an identical intervention protocol consisting of 45-minute supervised sessions, conducted twice weekly for 8 consecutive weeks during their pharmacological \"on\" phase. Standardized assessments will be performed by a blinded clinician at baseline and post-intervention (Week 8). The primary outcome measures will be dynamic balance and gait assessed through the Mini-Balance Evaluations Systems Test (Mini-BESTest) alongside global cognitive performance measured via the Montreal Cognitive Assessment (MoCA). Secondary outcomes will encompass objective posturographic indices using the Biodex Balance System, motor severity via the Unified Parkinson's Disease Rating Scale (UPDRS-III), freezing of gait, health-related quality of life, global perceived improvement, and potential cyber-sickness symptoms monitored through the Virtual Reality Sickness Questionnaire (VRSQ) to comprehensively determine the safety and comparative therapeutic value of these interventions.",[28,172,173,174,175,176,177],"Parkinson Disease (PD)","Parkinson s Disease","Postural Instability","Postural Instability Gait Disorders","Gait Disorders","Cognitive Dysfunction, Cognitive Disorder",[179,174,176,180,181,182],"Parkinson Disease","Cognitive Dysfunction","Dual Task","Virtual Reality","2026-06-23",{"date":96,"type":43},{"date":186,"type":22},"2026-06-20",{"date":188,"type":22},"2027-12-30",{"name":190,"class":50},"Bezmialem Vakif University",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":81},"100644240","phase-1-a-clinical-study-to-evaluate-the-safety-of-mf1-a-new-treatment-for-parkinsons-disease-related-disorders-mf1-study-100644240","NCT07666022","A Clinical Study to Evaluate the Safety of MF1, a New Treatment for Parkinson's Disease-related Disorders (MF1 Study)","A Phase I Investigator-initiated First-in-human Study to Evaluate the Safety and Pharmacokinetics of MF1 in Healthy Adults and Patients With Parkinson's Disease (MF1-FIH)","Inclusion Criteria:\n\n(Parts A and B)\n\n* 1)Healthy Japanese male adults aged \\>=18 and \\\u003C45 years at the time of informed consent.\n* 2\\) Subjects with a body mass index (BMI) of \\>=18.5 and \\\u003C25.0 kg\u002Fm2 at screening.\n* 3\\) Subjects who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.\n\n(Part C)\n\n* 1\\) Patients diagnosed with idiopathic Parkinson's disease according to the International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic Criteria (2015).\n* 2\\) Patients with Parkinson's disease classified as Stage 3 or below according to the modified Hoehn and Yahr staging scale.\n* 3\\) Patients who are either untreated or have been receiving one of the following treatments at a stable dosage regimen for at least 8 weeks prior to screening, with no planned changes during the study period: selegiline up to 5 mg twice daily, rasagiline up to 1 mg once daily, or immediate-release carbidopa\u002Flevodopa up to 25\u002F100 mg three times daily.\n* 4\\) Patients with an average Bristol Stool Scale score of \\\u003C=3 from the date of informed consent to eligibility assessment, or patients with fewer than two bowel movements per week.\n\nIf the period between informed consent and eligibility assessment is less than one week, information prior to informed consent will also be collected to assess bowel conditions for at least one week in total.\n\n* 5\\) Male or female patients aged \\>=40 and \\\u003C85 years at the time of informed consent.\n* 6\\) Patients with a BMI of \\>=18.5 and \\\u003C32.0 kg\u002Fm2 at screening.\n* 7\\) Female patients who are postmenopausal for at least one year at the time of informed consent, including menopause resulting from hysterectomy or oophorectomy.\n* 8\\) Patients who have received sufficient explanation regarding the study from the principal investigator or subinvestigator, have understood the objectives of the study, voluntarily agreed to participate, and have provided written informed consent of their own free will.\n\nExclusion Criteria:\n\n(Parts A and B)\n\n* 1\\) Subjects with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results.\n* 2\\) Subjects with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion.\n* 3\\) Subjects who used any medication, including over-the-counter drugs, within 7 days prior to the day before the first administration of the investigational product.\n* 4\\) Subjects with seizure disorders such as epilepsy, or a history thereof.\n* 5\\) Subjects with allergies or a history of allergies to drugs or foods.\n* 6\\) Subjects with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator.\n* 7\\) Subjects with current or past alcohol or drug dependence.\n* 8\\) Subjects who donated \\>=400 mL of whole blood within 12 weeks, \\>=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration.\n* 9\\) Subjects who tested positive at screening for HBs antigen, HCV antibody, HIV antigen\u002Fantibody, or syphilis serology (TP antibody test or RPR test).\n* 10\\) Subjects unwilling to use appropriate contraception from the time of informed consent until the final study visit.\n* 11\\) Subjects who answered \"Yes\" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening.\n* 12\\) Subjects who received investigational treatment in another clinical trial within 4 months prior to investigational product administration.\n* 13\\) Subjects judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations.\n\n(Part C)\n\n* 1\\) Patients with drug-induced parkinsonism, metabolic neurogenetic disorders, encephalitis, Parkinson-plus syndromes, or other atypical parkinsonian syndromes.\n* 2\\) Patients with freezing of gait.\n* 3\\) Patients with a history of stereotactic brain surgery for Parkinson's disease (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplantation).\n* 4\\) Patients with clinically significant cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunological, endocrine, or psychiatric disorders other than Parkinson's disease, or any other abnormalities that may affect safety, increase seizure risk, lower seizure threshold, or confound study results.\n* 5\\) Patients with current or past diseases or surgical histories involving the gastrointestinal tract, liver, kidneys, or other organs that may affect drug absorption, metabolism, or excretion.\n* 6\\) Patients with seizure disorders such as epilepsy, or a history thereof.\n* 7\\) Patients currently receiving antiplatelet agents or anticoagulants.\n* 8\\) Patients with allergies or a history of allergies to drugs or foods.\n* 9\\) Patients with allergic predisposition who are considered unsuitable for participation by the principal investigator or subinvestigator.\n* 10\\) Patients with current or past alcohol or drug dependence.\n* 11\\) Patients who donated \\>=400 mL of whole blood within 16 weeks, \\>=200 mL of whole blood within 4 weeks, or blood components within 2 weeks prior to investigational product administration.\n* 12\\) Patients who tested positive at screening for HBs antigen, HCV antibody, HIV antigen\u002Fantibody, or syphilis serology (TP antibody test or RPR test).\n* 13\\) Patients unwilling to use appropriate contraception from the time of informed consent until the final study visit.\n* 14\\) Patients who answered \"Yes\" to Question 4 or 5 regarding suicidal ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening, or who had a history of suicidal behavior within 6 months prior to screening.\n* 15\\) Patients who received investigational treatment in another clinical trial within 4 months prior to investigational product administration.\n* 16\\) Patients judged unsuitable for study participation by the principal investigator or subinvestigator based on findings from screening or admission assessments, observations, or examinations.","85 Years",{"count":200,"type":22},58,[202],"PHASE1","This is a Phase I, investigator-initiated, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of MF1, a novel agent that is expected to inhibit α-synuclein related pathogenesis in α-synucleinopathies, primarily Parkinson's disease (PD). MF1 aims to address the unmet medical need in PD, which affects about 1% of individuals aged 60 years and older in Japan and is projected to reach 43 million patients worldwide by 2050.\n\nThe trial consists of three parts: Part A (single ascending dose) and Part B (multiple ascending dose) in healthy Japanese male adults, and Part C (multiple dose) in patients with idiopathic PD. Part A is a randomized, double-blind, placebo-controlled, single-center study assessing single oral doses , including a food-effect evaluation. Part B is a randomized, double-blind, placebo-controlled, single-center study with once-daily dosing for 7 days. Part C is an open-label, multicenter study in 4-8 PD patients (MDS 2015 criteria, Hoehn \\& Yahr stage ≤3) receiving once daily for 14 days, with or without stable background antiparkinsonian therapy.\n\nThe primary objective is to assess safety and tolerability; secondary objectives include characterization of plasma, urine, and cerebrospinal fluid pharmacokinetics and assessment of food effect. Exploratory pharmacodynamic endpoints include biomarkers such as α-synuclein, neurofilament light chain, UCHL-1, FABP3, GFAP, and other neurodegeneration markers.\n\nKey exclusion criteria include clinically significant systemic diseases, seizure history, serious infections (HBV, HCV, HIV, syphilis), recent suicidal ideation or attempts, and recent use of other investigational products.",[205,28],"Healthy Adult Male",[207],"FIH","2026-06-18",{"date":125,"type":43},{"date":211,"type":43},"2026-06-01",{"date":213,"type":22},"2028-10-31",{"name":215,"class":50},"University of Shizuoka",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100644434","effects-of-tai-chi-therapy-versus-qi-gong-in-stage-i-parkinsons-patients-100644434","NCT07662837","Effects of Tai Chi Therapy Versus Qi-Gong in Stage-I Parkinson's Patients.","Effects of Tai Chi Therapy Versus Qi-Gong on Postural Control, Functional Balance , and Motor Function in Stage-I Parkinson's Patients.","Inclusion Criteria:\n\nDiagnosis of PD based on the Hoehn \\& Yahr staging system (Stages I). Male or female patients aged between 50-65 years. Currently receiving stable anti-Parkinsonian medication, with no changes in the treatment regimen for at least 3 months. Basic self-care ability with no severe cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score ≥24).\n\nExclusion Criteria:\n\nDepression, as assessed based on a score of \\>16 for the Beck Depression Inventory-II (BDI-II). Recent deep brain stimulation (DBS) treatment. Use of medication that interferes with cognition, alertness, or attention. Current participation in an exercise training program.","65 Years",{"count":225,"type":22},50,[64],"This study has important clinical, academic, and practical relevance in neuromuscular rehabilitation. Clinically, it aims to identify effective and tolerable rehabilitation strategies for individuals with Parkinson's disease by comparing Tai Chi Therapy with Qi-Gong there by supporting evidence-based physiotherapy practice and improving patient adherence. Academically, it contributes to the limited literature on comparative effectiveness of these interventions and incorporates patient-centered outcomes such as exercise perception, which are often underreported. From a practical and societal perspective, identifying a more acceptable and effective approach may enhance long-term participation in rehabilitation, potentially slow disease progression, and reduce the overall healthcare burden associated with Parkinson's disease.",[28],[230,231],"Tai Chi","Qi-Gong","2026-06-17",{"date":183,"type":43},{"date":235,"type":43},"2026-05-30",{"date":237,"type":22},"2026-10-10",{"name":239,"class":50},"Lahore University of Biological and Applied Sciences",2,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":81},"100635824","phase-1-using-tavns-to-modulate-cardiovascular-function-in-individuals-with-neurologic-disease-100635824","NCT07557706","Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic PD\n* Stable medication for at least 4 weeks prior to the study\n\nExclusion Criteria:\n\n* Use of beta blockers\n* Sustained severe hypertension (\\>\u002F= 180\u002F110 mmHg while seated)\n* Significant uncontrolled cardiac arrhythmia\n* Unstable angina\n* Congestive heart failure\n* History of myocardial infarction\n* History of seizures\n* Severe cognitive impairment\n* Pregnant women or women who are planning to become pregnant",{"count":248,"type":22},24,[202],"The purpose of this study is to find out whether a type of gentle nerve stimulation, called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the body regulates heart rate and blood pressure in people with Parkinson's Disease (PD). Problems with heart rate and blood pressure control are common and can make it harder for people to exercise or do daily activities. By using this non-invasive form of nerve stimulation and testing how it affects the body's natural responses, this study hopes to learn if taVNS could be a helpful tool to support physical therapy and improve overall function.",[28],[253,254,255],"vagus nerve stimulation","neuromodulation","parkinson's disease","2026-06-16",{"date":208,"type":43},{"date":259,"type":43},"2025-09-15",{"date":261,"type":22},"2026-12-31",{"name":263,"class":50},"University of Alabama at Birmingham",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":60,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":285,"locationsCount":81},"100635603","effects-of-accelerated-rtms-on-motor-and-cognitive-function-in-parkinsons-disease-100635603","NCT07554833","Effects of Accelerated rTMS On Motor and Cognitive Function in Parkinson's Disease","Clinical Effects of Accelerated rTMS Targeting Motor Cortex on Motor and Cognitive Function in Parkinson's Disease: A Prospective Pilot Study","Inclusion Criteria:\n\n* Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent.\n* Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria or UK Parkinson's Disease Society Brain Bank criteria.\n* Hoehn and Yahr stage 1-3 (mild to moderate disease severity).\n* MDS-UPDRS-III (Motor Examination) score ≥10 at screening.\n* Stable doses of anti-parkinsonian medications (including levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine) for at least 4 weeks prior to screening, with no anticipated changes during the study period.\n* Ability to provide written informed consent.\n* Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Sufficient visual and auditory acuity to complete motor and cognitive assessments.\n* Availability and willingness to complete all scheduled study visits.\n* Presence of a reliable study partner or caregiver who can provide information about the participant's motor, cognitive, and functional status.\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the contralateral hand muscles.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in motor or cognitive function, including non-invasive brain stimulation treatments other than the study procedure during study participation.\n* Subjects willing and able to maintain their regular (pre-procedure) medication regimen, diet, and exercise routine without affecting significant change in either direction during study participation.\n* Willingness to comply with study instructions and to return to the clinic for the required visits.\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.\n\nExclusion Criteria:\n\n* Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.\n* Metallic, ferromagnetic, or other magnetic-sensitive implants\u002Fobjects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.\n* Drug pumps within 12 inches (30 cm) of the therapy coil.\n* Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the contralateral hand muscles cannot be established).\n* History of seizure disorder or epilepsy, except for a single remote seizure more than 5 years ago, which may be permitted at investigator discretion.\n* Elevated risk of seizure due to traumatic brain injury with loss of consciousness \\>30 minutes within the past 12 months.\n* Current use of medications known to significantly lower seizure threshold (e.g., clozapine, bupropion at doses \\>450 mg\u002Fday, theophylline, high-dose tricyclic antidepressants) or recent dose reduction of anticonvulsant medications or benzodiazepines within 4 weeks of screening.\n* Atypical parkinsonism or Parkinson-plus syndromes (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration).\n* Hoehn and Yahr stage 4 or 5 (severe disease with significant disability).\n* Severe dementia, defined as MoCA score below 10, or inability to follow simple verbal commands or complete basic motor and cognitive assessments.\n* Rapidly progressive cognitive decline or suspected prion disease, autoimmune encephalitis.\n* Brain tumor, intracranial hemorrhage within the past 12 months, arteriovenous malformation, or increased intracranial pressure.\n* Acute stroke within the past 3 months.\n* Prior deep brain stimulation (DBS) surgery or other neurosurgical procedures for Parkinson's disease.\n* Has a current diagnosis of psychotic disorder, bipolar disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.\n* Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening.\n* History of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening, or positive test result(s) for drugs of abuse (including opiates, cocaine, cannabinoids, methamphetamines, amphetamines) at screening.\n* Has history of or current clinically significant and\u002For unstable medical condition that could interfere with study participation or pose safety concerns, including but not limited to: Moderate or severe hepatic impairment (Child-Pugh Score ≥7); Severe renal impairment (estimated creatinine clearance below 30 mL\u002Fmin or serum creatinine \\>2 mg\u002FdL); Unstable cardiac, vascular, or pulmonary disease Note: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator.\n* Has uncontrolled hypertension (systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>100 mm Hg, despite diet, exercise, or a stable dose of antihypertensive therapy) at screening.\n* Has clinically significant ECG abnormalities at screening, defined as: QTc interval (Fridericia's formula): ≥450 msec (males); ≥470 msec (females); Evidence of 2nd or 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \\>210 msec; Left bundle branch block; Features of new ischemia; Other clinically important arrhythmia\n* Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, is considered cured with minimal risk of recurrence).\n* Had clinically significant acute illness within 7 days prior to study rTMS treatment.\n* Had major surgery (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n* Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.\n* Has received an investigational drug or used an invasive investigational medical device within 3 months before screening, or is currently enrolled in an investigational study.\n* Prior treatment with rTMS within 6 months of screening.\n* Subjects willing to partake in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure, during study participation.\n* Has psychological and\u002For emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.",{"count":272,"type":22},40,[64],"Parkinson's disease (PD) is a brain disorder that causes progressive problems with movement, such as slowness, stiffness, tremor, and difficulty walking. Many people with PD also develop problems with thinking and memory. Current medications can help control movement symptoms but often become less effective over time and may cause side effects. There is a need for additional treatment options that can address both movement and thinking difficulties in PD.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses delivered to the scalp to stimulate specific areas of the brain. Previous research has shown that rTMS targeting the motor cortex (the part of the brain that controls movement) can improve motor symptoms in people with PD.\n\nThe purpose of this pilot study is to evaluate whether an accelerated course of rTMS targeting the motor cortex can improve movement and thinking abilities in people with mild to moderate Parkinson's disease. The study will enroll 40 participants aged 50 to 90 years at the San Francisco Neurology and Sleep Center.\n\nParticipants will receive 6 sessions of rTMS using the EXOMIND™ device, administered twice per week over approximately 3 weeks. Each session delivers high-frequency magnetic stimulation to the motor cortex on both sides of the brain. Participants will be assessed before treatment, at the last treatment session, and at 1-month and 3-month follow-up visits.\n\nThe primary outcome measure is the change in motor symptoms as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) at 1 month after treatment. Secondary outcomes include additional measures of walking and gait, domain-specific cognitive testing using the Creyos cognitive battery (assessing memory, attention, reasoning, and other thinking skills), the Montreal Cognitive Assessment (MoCA), depression symptoms (PHQ-9), and quality of life (PDQ-39).\n\nThis is a single-center, open-label study with no placebo or control group. Total participation duration is up to 139 days, including screening, treatment, and follow-up visits.",[28,173],[277,278,119,150,279],"rTMS","ExoMind","Cognitive Function","2026-06-12",{"date":256,"type":43},{"date":283,"type":22},"2026-06-03",{"date":102,"type":22},{"name":286,"class":50},"San Francisco Neurology and Sleep Center",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":314,"locationsCount":4},"100643119","telerehabilitation-versus-face-to-face-lsvt-big-in-individuals-with-parkinson-disease-100643119","NCT07630792","Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease","The Effects of Telerehabilitation and Face-to-Face LSVT BIG Method on Motor and Non-Motor Symptoms in Individuals With Parkinson Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease\n* Hoehn and Yahr stage 1-3\n* Montreal Cognitive Assessment (MoCA) score ≥ 21\n* Ability to use a smartphone, tablet, or computer\n* Access to internet connection and basic digital literacy\n* Participation in activities outside the home at least 3 days per week\n\nExclusion Criteria:\n\n* Diagnosis of a neurological condition other than idiopathic Parkinson's disease\n* Change in antiparkinsonian medication regimen during the study period\n* History of deep brain stimulation\n* Visual or hearing impairment that would prevent participation in treatment or assessments\n* Severe cardiovascular, orthopedic, pulmonary, or systemic comorbidity contraindicating exercise\n* Diagnosis of severe depression, psychotic disorder, or uncontrolled psychiatric illness\n* Participation in another structured physiotherapy or rehabilitation program for\n* Parkinson's disease within the last three months",{"count":272,"type":22},[64],"This prospective, randomized controlled trial will enroll 40 individuals with idiopathic PD (Hoehn \\& Yahr stages 1-3, MoCA ≥21). Participants will be randomly assigned in a 1:1 ratio to either a telerehabilitation LSVT BIG group or a face-to-face LSVT BIG group, with randomization stratified by Hoehn \\& Yahr stage using a computer-based block randomization system. Both groups will receive the standard LSVT BIG® protocol consisting of 16 sessions over four weeks (4 days\u002Fweek, 1 hour\u002Fsession). Treatment content will include maximal daily exercises, functional component tasks, \"big\" gait training, and individually tailored hierarchy tasks. The telerehabilitation group will receive all sessions via synchronous video conferencing under physiotherapist supervision, while the face-to-face group will receive sessions in a clinical setting. Both groups will be assigned home exercise programs in accordance with the LSVT BIG® protocol, and treatment adherence will be monitored throughout the study.\n\nOutcomes will be assessed at baseline, after 4 weeks of treatment, and at 6-month follow-up. Primary outcomes include postural stability and fall risk assessed with the Biodex Balance System (anterior-posterior stability index, mediolateral stability index, general stability index, fall risk index, limits of stability) and motor and non-motor symptom severity assessed with the MDS-UPDRS (Parts I, II, and III). Secondary outcomes include dynamic balance (Mini-BESTest), functional mobility (Timed Up and Go Test, 10-Meter Walk Test), quality of life (PDQ-39), depression (Beck Depression Inventory), sleep quality (Parkinson's Disease Sleep Scale), fatigue (Parkinson Fatigue Scale), cognitive function (MoCA), and treatment satisfaction (Global Rating of Change Scale).",[28,298,179],"Parkinson Disease (PD), Postural Balance",[179,300,301,302,303,304,305,306,307],"LSVT BIG","Telerehabilitation","Motor Symptoms","Non-Motor Symptoms","Balance","Neuroplasticity","Randomized Controlled Trial","Physical Therapy","2026-06-09",{"date":310,"type":43},"2026-06-11",{"date":186,"type":22},{"date":313,"type":22},"2028-06-30",{"name":190,"class":50},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":4},"100643698","auto-calibrating-system-for-upper-limb-disability-assessment-neurological-and-occupational-rehabilitation-100643698","NCT07636538","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation","Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation (AS-ULDAR)","ASULDAR","Inclusion Criteria:\n\n* Adult patients aged between 18 and 80 years.\n* Confirmed diagnosis of one of the following neurological conditions: stroke, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), or Mild Cognitive Impairment (MCI).\n* Presence of upper limb motor impairment defined by QuickDASH scores ranging from 20 to 90.\n* Ability to understand and follow the study protocol instructions.\n\nExclusion Criteria:\n\n* Patients with severe psychiatric disorders or cognitive impairments that interfere with the ability to complete cognitive tests and self-assessment scales.\n* Individuals unable to provide informed consent.\n* Subjects with moderate to severe cognitive impairment, defined by an ECAS score lower than 81.92 (ALS patients) or a MoCA score between 18 and 25.\n* Physical conditions significantly limiting upper limb use (e.g., severe concomitant orthopedic disorders affecting shoulder movement).\n* Current or recent participation (within the previous three months) in other rehabilitation programs or interventions that could influence study outcomes.\n* Unstable health conditions that could make device use unsafe or inappropriate, including unstable medical conditions or severe visual impairments.",{"count":324,"type":22},30,[64],"This interventional, multicenter, low-intervention clinical trial aims to evaluate the usability, feasibility, safety, and preliminary clinical impact of a robotic rehabilitation system designed for upper limb rehabilitation in adults with neurological disorders, including Parkinson's disease (PD), Amyotrophic Lateral Sclerosis (ALS), post-stroke sequelae, and Mild Cognitive Impairment (MCI).\n\nThe system under study combines a collaborative robot (cobot), inertial sensors, and a graphical user interface capable of supporting reaching exercises, trajectory tracking activities, and cognitive exergames, while also enabling automatic acquisition and visualization of patient performance data.\n\nThe main questions the study aims to answer are:\n\nIs the investigational robotic rehabilitation system usable and feasible in neurological patients undergoing upper limb rehabilitation? Is the use of the device safe for both patients and healthcare operators? Does the addition of robotic-assisted rehabilitation to conventional therapy improve upper limb motor performance, cognitive function, and quality of life compared with conventional rehabilitation alone? Do movement measurements collected by the system correlate with standard clinical assessment scales?\n\nResearchers will compare conventional rehabilitation therapy plus robotic-assisted rehabilitation with conventional rehabilitation therapy alone to evaluate the impact of the device on motor, cognitive, and psychosocial outcomes.\n\nThirty participants will be randomized into two parallel treatment groups. Both groups will receive 12 sessions of conventional rehabilitation therapy lasting 60 minutes each, three times per week. Participants assigned to the experimental group will additionally receive robotic-assisted rehabilitation sessions of up to 30 minutes supervised by rehabilitation staff.\n\nParticipants will undergo:\n\nBaseline collection of demographic and clinical information; Motor, cognitive, and activities of daily living assessments using standardized clinical scales; Conventional rehabilitation therapy sessions; Robotic-assisted upper limb rehabilitation exercises, including task-oriented and trajectory-tracking activities (experimental group only); Monitoring of vital parameters and adverse events during device use; Final evaluation of usability, psychosocial impact, patient satisfaction, motor and cognitive outcomes, and safety.",[328,329,28,330],"Stroke","Amyotrophic Lateral Sclerosis","Mild Cognitive Impairment (MCI)",[332,333,334,335],"Collaborative Robot","Robotic rehabilitation","Neurological disorders","Graphical User Interface",{"date":308,"type":43},{"date":338,"type":22},"2026-06",{"date":340,"type":22},"2026-10",{"name":342,"class":50},"University of Pavia",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100625441","phase-1-sad-study-in-patients-with-parkinsons-disease-and-motor-fluctuations-100625441","NCT07422675","SAD Study in Patients With Parkinson's Disease and Motor Fluctuations","A Randomized, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of SER-252 in Patients With Parkinson's Disease and Motor Fluctuations","Inclusion criteria\n\n1. Female or male participants 40-80 years of age, inclusive, at the time of screening\n2. Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria; must include bradykinesia with sequence effect, motor asymmetry if no rest tremor, and a reliable, visible response to levodopa\n3. On a stable regimen of anti-Parkinsonian medication for at least 4 weeks prior to Screening; MAOBIs must be stable for at least 12 weeks prior to Screening\n4. Routine early-morning OFF, corroborated by investigator interview at Screening\n5. Presence of a total daily OFF time duration of ≥2 hours during the waking day based on participant self-assessment and Investigator's judgment\n6. \\*Hoehn and Yahr scale ≤ 3 in the ON state during screening (\\*part of the MDS- UPDRS Part III assessment)\n7. Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)\n8. Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort\n9. Montreal Cognitive Assessment ≥ 24\n10. Women of child-bearing potential (WOCBP) who are sexually active with a male partner must use a reliable method of contraception from the time of consent through at least 3 months after the last dose of study medication. Reliable methods of contraception include oral contraceptive or long-term injectable or implantable hormonal contraceptive, or intra-uterine devices when used in combination with male condoms, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline. Males who are sexually active and whose partners are females of childbearing potential must agree to use male condoms from the time of consent through 3 months after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 3 months after administration of the last dose of study drug.\n11. Willing and able to comply with all study activities and requirements, including safety follow-up\n12. Provide written informed consent\n13. Approved by a central Enrollment Authorization Committee (EAC)\n\nExclusion criteria\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., DBS), or anticipation of these during the study\n3. History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia\n4. Clinically debilitating motor complications as determined by the principal investigator or delegate (severe, disabling dyskinesias or severe OFF)\n5. Participant inability to differentiate motor states (OFF\u002FON\u002FON with mild\u002Fmoderate\u002Fsevere dyskinesias) after training\n6. Clinically significant orthostatic hypotension (consistently symptomatic or requires medication)\n7. Clinically significant hallucinations requiring antipsychotic use\n8. Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the principal investigator or delegate would preclude adequate participation or completion of the study\n9. Clinically significant ECG abnormalities at Screening\n10. Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening (defined as a QTcF interval of \\>450 msec for males and 470 for females)\n11. Clinically significant heart disease within 2 years of Screening, defined as follows:\n\n    A. Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms \\> grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia B. History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (Common Terminology Criteria for Adverse Events grade 3) C. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia D. Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker E. Unexplained syncope F. Brugada syndrome G. Hypertrophic cardiomyopathy\n12. Active major depressive disorder or history of clinically significant impulse control disorder, in the opinion of the Principal Investigator or delegate, or EAC.\n\n    Note: Participants receiving treatment for depression with antidepressants may be enrolled if they have been on a stable daily dose of the antidepressant for at least 8 weeks prior to Screening.\n13. Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS (answer of \"yes\" on questions 4 or 5) or attempted suicide within the last 5 years\n14. Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by DSM-V criteria, during the 12 months prior to Screening\n15. Tests positive at Screening for drugs of abuse (amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), opiates (OPI), methamphetamines (MET), methadone (MTD), Phencyclidine (PCP), tetrahydrocannabinol (THC), tricyclic antidepressants (TCA)) Note: does not exclude patients on physician-prescribed medications.\n16. Has ALT or AST levels greater than 2.5 times the ULN or bilirubin \\> 2.0 mg\u002FdL, or \\> 34.2 µmol\u002FL\n17. Significant renal impairment as determined by eGFR, using Cockcroft-Gault method, less than or equal to 55 ml\u002Fmin or serum creatinine \\>2.0 mg\u002FdL or \\>177 µmol\u002FL\n18. Has a positive test result for HBsAg, HCV antibody, or HIV infection at Screening\n19. Currently lactating or pregnant or planning to become pregnant during the study.\n20. Previous intolerance of apomorphine\n21. Currently participating in or has participated in another investigational study within the last 30 days or 5 half-lives, or 90 days for biologics",{"count":272,"type":22},[202],"This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.",[28,354],"Advanced Parkinson's Disease",[356],"advanced Parkinson's Disease",{"date":358,"type":43},"2026-06-05",{"date":360,"type":43},"2026-02-01",{"date":362,"type":22},"2027-01-31",{"name":364,"class":159},"Serina Therapeutics",6,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":374,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":240},"100643586","local-field-potential-correlates-of-neuropsychiatric-symptoms-in-parkinsons-disease-100643586","NCT07633379","Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease","Intracranial Local Field Potential (LFP) Correlates of Neuropsychiatric Symptoms in Parkinson's Disease","LFP-in-PD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* A diagnosis of Parkinson's Disease\n* A diagnosis of hallucinations, impulse control disorder, or panic disorder (episodic anxiety)\n* Previous bilateral DBS implantation with a Medtronic Percept device as part of clinical care\n\nExclusion Criteria:\n\n* Non-English speakers\n* \\\u003C18 years old or \\>75 years old\n* A history of concurrent conditions that could significantly confound the study results, such as other significant neurological condition (e.g., brain injury\u002Finfection, substance abuse) or concurrent severe psychiatric condition (e.g., schizophrenia)\n* Moderate\u002Fsevere Intellectual Disability or inability to understand study procedures\n* Lack of capacity to consent to the study\n* Currently involvement in other studies",{"count":113,"type":22},"This prospective observational cohort study aims to investigate whether intracranial Local Field Potentials (LFPs) recorded from implanted Deep Brain Stimulation (DBS) devices are associated with neuropsychiatric symptoms in people with Parkinson's disease (PD). The study will focus on paroxysmal anxiety, impulse control disorders, and hallucinations.\n\nTwenty participants with Parkinson's disease and an implanted Medtronic Percept DBS device will be recruited. Participants will complete behavioural and clinical assessments and will use the event-marking functionality of the DBS device to record symptom episodes over a monitoring period of approximately 120 days. Brain activity will be passively recorded during this period.\n\nThe study will evaluate relationships between LFP signals, symptom occurrence, behavioural task performance, and clinical symptom severity measures. Machine learning approaches will be used to identify electrophysiological patterns associated with neuropsychiatric symptom states at an individual level.\n\nThe findings may improve understanding of the neural mechanisms underlying neuropsychiatric symptoms in Parkinson's disease and support the future development of personalised adaptive neuromodulation approaches.",[28],"2026-06-02",{"date":379,"type":43},"2026-06-08",{"date":211,"type":22},{"date":382,"type":22},"2028-02-01",{"name":384,"class":50},"King's College London",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":81},"100638187","feasibility-of-a-community-based-multimodal-exercise-programme-in-parkinsons-disease-100638187","NCT07618728","Feasibility of a Community-Based Multimodal Exercise Programme in Parkinson's Disease","Feasibility and Preliminary Effectiveness of an Individualised Multimodal Group-Based Exercise Programme for People With Parkinson's Disease: A Non-Randomized Feasibility Study","Eligibility Criteria The eligibility criteria will be identical for both the experimental and control groups. However, this study will employ a sequential recruitment design. Participants for the control group will be recruited following the experimental group and will be matched (1:1 ratio) based on sex, age (± 5 years), and disease severity according to the Hoehn \\& Yahr (H\\&Y) scale.\n\nInclusion Criteria:\n\n* Subjects diagnosed with Idiopathic Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria.\n* Subjects staged between 1 and 3 on the Hoehn \\& Yahr Scale. For matching purposes, stage 1 includes stage 1.5, and stage 2 includes stage 2.5.\n\nExclusion Criteria:\n\n* Subjects diagnosed with a neurological disease other than PD.\n* Those diagnosed with a cardiovascular, respiratory, or metabolic disease or other conditions that represent a contraindication to physical exercise.\n* Those who have suffered an exacerbation or hospitalization in the last three months prior to starting the assessment protocol or during the therapeutic intervention process.\n* Those who have received a course of steroids, intravenously or orally, six months prior to the start of the study or during the therapeutic intervention process.\n* Those with cognitive impairment (defined as a score \\\u003C 21 on the Montreal Cognitive Assessment, MoCA) or language impairments that prevent adequate communication, comprehension, or following of exercise instructions.\n* Participation in a structured, individualized strength and\u002For aerobic exercise program within the three months prior to enrollment.",{"count":393,"type":22},64,[64],"This study aims to evaluate the feasibility and preliminary effectiveness of a multimodal, group-based but individualised therapeutic exercise programme for people with Parkinson's disease delivered within a real-world community-based patient association setting.\n\nThe primary objective is to assess the feasibility of implementing the programme, including recruitment, consent, adherence, intervention completion, acceptability, perceived exertion and safety. Secondary objectives are to obtain preliminary comparative information regarding the effects of the intervention on motor and non-motor symptoms, physical fitness, pain-related outcomes and exercise-induced hypoalgesia.\n\nThis is a non-randomized sequential feasibility study including an intervention group participating in a 12-week multimodal exercise programme and a matched non-exercise control group maintaining usual activities. Outcomes will be assessed at baseline, post-intervention and 6-month follow-up.",[28],[119,398,399,400,401,402,403],"Exercise programme","Feasibility","Multimodal","Individualised","Motor symptoms","Non-motor symptoms",{"date":283,"type":43},{"date":406,"type":43},"2025-09-08",{"date":408,"type":22},"2027-09",{"name":410,"class":50},"Universidad Rey Juan Carlos",{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":88,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":419,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":421,"conditions":422,"keywords":427,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":240},"100640300","early-molecular-biomarkers-for-differentiating-parkinsonian-syndromes-100640300","NCT07604883","Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes","Identification of Molecular Biomarkers, Including microRNAs and Metabolites, Enabling Early Differentiation of Parkinson's Disease and Atypical Parkinsonian Syndromes in a Prospective Observational Study.","BIOMARK-PS","Inclusion Criteria:\n\nPatients with suspected neurodegenerative parkinsonism in the course of PD or APS, defined according to the 2015 MDS criteria as bradykinesia accompanied by at least one additional symptom: rigidity and\u002For resting tremor.\n\nAge between 40 and 80 years. Written informed consent for participation in the study. Duration of parkinsonian symptoms shorter than 3 years. Abnormal dopamine transporter single-photon emission computed tomography (DaTscan) result confirming presynaptic dopaminergic neuronal degeneration.\n\nExclusion Criteria Lack of consent to participate in the study. Secondary or drug-induced parkinsonism. Other central nervous system (CNS) disorders (e.g., neoplastic or vascular processes) that could account for the symptoms.\n\nActive malignancy, infection, or autoimmune inflammatory disease. Severe systemic diseases, including advanced heart failure (New York Heart Association \\[NYHA\\] class III-IV), poorly controlled diabetes mellitus, renal failure with glomerular filtration rate (GFR) ≤ 60 mL\u002Fmin\u002F1.73 m², or hepatic failure.\n\nPresence of a known monogenic mutation causing parkinsonism according to the Online Mendelian Inheritance in Man (OMIM) classification.\n\nAntibiotic therapy or use of probiotics within 3 months prior to the study visit.\n\nPregnancy or breastfeeding.",{"count":420,"type":22},200,"This prospective observational study aims to identify and preliminarily validate molecular biomarkers, including microRNAs and metabolites, for the early differentiation of Parkinson's disease (PD) from atypical parkinsonian syndromes (APS). The study will enroll up to 100 patients with PD, 50 patients with suspected APS, and 50 healthy controls.\n\nParticipants will undergo clinical assessments and provide blood, urine, and stool samples at baseline and after 12-18 months of follow-up. Molecular analyses, including microRNA profiling, metabolomics, RNA sequencing (RNA-seq), and microbiome analysis, will be performed to identify disease-specific diagnostic signatures.\n\nThe primary objective is to detect differences in molecular profiles among patients with PD, patients with APS, and healthy controls. Secondary objectives include evaluating the diagnostic accuracy of biomarker panels and assessing longitudinal changes in these biomarkers over time.\n\nAlthough participants will not receive direct therapeutic benefits, the study may contribute to the development of non-invasive tools for the early diagnosis and improved differentiation of parkinsonian disorders.",[28,423,424,425,426],"Atypical Parkinsonism","Multiple System Atrophy","Progressive Supranuclear Palsy (PSP)","Dementia With Lewy Bodies (DLB)",[428,429,430,431,432,433],"parkinson disease","atypical parkinsonism","progressive supranuclear palsy","multiple system atrophy","dementia with lewy bodies","biomarker","2026-05-25",{"date":436,"type":43},"2026-05-28",{"date":438,"type":22},"2026-06-04",{"date":440,"type":22},"2029-06-04",{"name":442,"class":443},"International Institute of Molecular and Cell Biology in Warsaw","OTHER_GOV",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":457,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":463,"leadSponsor":465,"locationsCount":81},"100607580","multicontext-approach-for-cognitive-function-in-parkinson-disease-100607580","NCT07190404","Multicontext Approach for Cognitive Function in Parkinson Disease","Efficacy and Mechanisms of a Metacognitive Strategy Intervention for Parkinson Disease-Related Cognitive Decline.","MC4PD R01","Inclusion criteria:\n\n1. Males and females over age 50 who meet criteria for typical idiopathic PD.\n2. Hoehn \\& Yahr stage I-III.\n3. Have subjective cognitive decline (SCD) as defined by a positive answer to either question:\n\n   * Do you feel like your thinking skills or memory are becoming worse or are worse than others your age?\n   * Do you have problems or concerns with your thinking skills or memory?, and can list ≥1 daily cognitive challenge they want to address.\n4. Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); unplanned changes and changes over the follow-up period will be tracked and accounted for as appropriate.\n\nExclusion criteria:\n\n1. Dementia according to MDS criteria or MoCA score \\\u003C21.\n2. Other neurological disorders (e.g., stroke, seizures).\n3. Current or history of major psychiatric disorder or psychotic symptoms (e.g., schizophrenia, bipolar disorder, delusions, hallucinations), drug abuse. Psychiatric conditions\u002Fsymptoms that are common in PD (e.g., anxiety, depression) are permitted if deemed insufficient to interfere with participation.\n4. Other circumstance that would interfere with participation (e.g., non-English speaking, blindness, lives \\>50mi away).",{"count":453,"type":22},114,[64],"Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem.\n\nUnfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD.\n\nStudy participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.",[28],[179,458],"occupational therapy","2026-05-20",{"date":461,"type":43},"2026-05-26",{"date":459,"type":22},{"date":464,"type":22},"2030-08-31",{"name":466,"class":50},"Washington University School of Medicine",{"id":468,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":26,"conditions":471,"keywords":472,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":476,"leadSponsor":477,"locationsCount":478},"100604581",{"count":21,"type":22},[25],[28],[30,31,32,33,34,35,36,37,38],{"date":474,"type":43},"2026-05-22",{"date":45,"type":43},{"date":47,"type":22},{"name":49,"class":50},4,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":81},"100637074","home-based-exercise-programs-for-fall-prevention-in-parkinson-disease-100637074","NCT07590700","Home-Based Exercise Programs for Fall Prevention in Parkinson Disease","Effectiveness of Fall-Preventive Home Exercise Programs in Patients With Parkinson Disease: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosis of Parkinson disease confirmed by a neurologist\n* Hoehn and Yahr stage 3 or 4 Parkinson disease\n* Diagnosis of Parkinson disease for at least 5 years\n* Willingness to participate in the study and provide written informed consent\n* Ability to walk independently or with minimal assistance\n* Mini-Mental State Examination score \\>24\n\nExclusion Criteria:\n\n* Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease\n* Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy\n* History of serious fall-related injury or surgery within the last 6 months\n* Any additional health condition that would prevent participation in the exercise program during the study period",{"count":324,"type":22},[64],"Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population.\n\nThis randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks.\n\nParticipants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.",[28,490,491],"Falls Prevention","Exercise",[428,493,494,495,496],"fall prevention","Otago","Home-based","Execise","2026-05-15",{"date":499,"type":43},"2026-05-19",{"date":501,"type":43},"2026-02-08",{"date":503,"type":22},"2026-08",{"name":505,"class":50},"Uludag University",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":516,"conditions":517,"keywords":520,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":81},"100637395","physical-activity-in-persons-with-parkinsons-disease-100637395","NCT07585409","Physical Activity in Persons With Parkinson's Disease","Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study","ActivPARK","Inclusion Criteria:\n\n* People diagnosed with idiopathic Parkinson's disease\n* Hoehn \\& Yahr 1 to 4\n\nExclusion Criteria:\n\n* Hoehn \\& Yahr 5 (i.e. wheelchair bound or bedridden unless aided)\n* Unable to perform critical physical activity and clinical assessments",{"count":515,"type":22},450,"This project aims to identify why some people with Parkinson's disease (PwPD) become less physically active, and which factors support or hinder activity. Understanding these factors is essential for developing person centred interventions and effective support that can be implemented in routine healthcare. A national, multicentre longitudinal cohort study will be conducted including approx 450 PwPD from five Swedish regions (including the internal pilot NCT06901869). Physical activity will be measured objectively with activity monitors, combined with clinical assessments and digital questionnaires over four years. The primary outcome is physical activity level (accelerometer measured decline), and exposure variables include physical, cognitive, disease specific, social, environmental, motivational, and personal factors. Data collection involves clinical tests, questionnaires, accelerometer data, and patient reported experiences.\n\nThis is a continuation of an internal pilot study NCT06901869. The study will enable early identification of those at risk for declining activity and guide development of person centred, evidence based interventions. Long term, it aims to integrate activity monitoring and risk factor screening into routine care to improve health and quality of life for PwPD.",[28,518,519],"Physical Activity","Sedentary Behaviors",[521,522,523,524],"Parkinson's disease","Physical activity","activity monitors","accelerometers","2026-05-13",{"date":497,"type":43},{"date":528,"type":43},"2026-01-15",{"date":530,"type":22},"2031-01-30",{"name":532,"class":50},"Karolinska Institutet",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":81},"100631255","adapting-rhire-and-sleep-monitoring-in-parkinsons-disease-100631255","NCT07498296","Adapting rHIRE and Sleep Monitoring in Parkinson's Disease","Adapting High-Intensity Exercise and Sleep Monitoring Technology for Home Use in Parkinson's Disease","Adapt rHIRE","Inclusion Criteria:\n\n* Currently residing in Colorado, USA\n* PD diagnosis per Movement Disorders Society Diagnostic Criteria\n* Requiring less than minimal assistance at home\n* Having internet access\n* Having a video-capable device\n\nExclusion Criteria:\n\n* Uncontrolled cardiovascular disease or pulmonary disease\n* Musculoskeletal injuries\n* Participation in Parkinson's Disease community exercise programs more than 3 days a week\n* Contraindication to physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)\n* Fall risk defined by requiring \\>20 seconds to complete the 5 times sit to stand test14 or high frequency of falls within the past year (≥ one fall per month)\n* Virtual Montreal Cognitive Assessment (MoCA) score ≥ 18 (performed at the eligibility visit)",{"count":542,"type":22},16,[64],"Exercise is a primary intervention for symptom management in Parkinson's Disease (PD). However, challenges related to transportation, mobility, and socioeconomic factors often hinder consistent participation in exercise programs. To promote increased access and participation, remote exercise programs offer a promising solution.\n\nThe investigators previously showed that laboratory-based, high-intensity resistance exercise improves sleep efficiency in individuals with PD in a randomized, controlled, clinical trial. The investigators aim to adapt this protocol for remote delivery and to evaluate the usability of a remote sleep-monitoring device in people with Parkinson's Disease (PwP). Guided by the IDEAS framework for digital health intervention design, the investigators will modify the exercise protocol to ensure safety, accessibility, and fidelity in a home setting. Specific aims include: (1) assessing the adaptability of the HIRE protocol for remote implementation through participant acceptability ratings, adherence, exertion levels, and safety outcomes, (2) evaluating the usability of the Waveband sleep monitoring headband and adherence to night wear schedules, and 3) gather qualitative feedback through semi-structured interviews to understand participant perspectives on protocol design, session completion, and safety.\n\nBy integrating behavioral theory, participant engagement, and real-world constraints, this research will inform scalable, home-based interventions that are both effective and responsive to the lived experiences of PwP. The findings will lay the groundwork for future clinical trials and broader dissemination of remote therapeutic strategies in neurodegenerative care.",[28],[547,548,255,549,550],"exercise","remote exercise","feasibility","sleep monitoring",{"date":497,"type":43},{"date":553,"type":43},"2026-03-05",{"date":555,"type":22},"2026-11-15",{"name":557,"class":50},"University of Colorado, Denver",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":578,"locationsCount":81},"100640649","retraining-gait-in-parkinsons-disease-via-a-personalised-app-100640649","NCT07584993","Retraining Gait in Parkinson's Disease Via a Personalised App","CuePD in the Home: Retraining Gait in Parkinson's Disease Via a Personalised App","CuePD-Extend","Inclusion Criteria:\n\n* Able to walk unaided.\n* Diagnosis of idiopathic Parkinson's.\n* Score ≥21\u002F30 on Montreal Cognitive Assessment (MoCA) which is used to classify non-demented Parkinson's (Parkinson's dementia is \\\u003C21\u002F30).\n* Uses a smartphone.\n\nExclusion Criteria:\n\n* Non-English speakers\n* Use of any mobility aids e.g., walking stick\n* History of stroke, traumatic brain injury or other neurological disorders (other than Parkinson's)\n* Unable to comply with the testing protocol or currently participating in another interfering research project.\n* Does not use a smartphone.\n* Body mass index ≥35 (i.e., severe to morbid obesity)",{"count":272,"type":22},[64],"Introduction Parkinson's disease (PD) limits mobility by worsening gait\u002Fwalking and increasing fall risk. Falls lead to injuries and reduce confidence in performing everyday tasks. That lowers a person's ability to participate in community activities such as going to the shops or visiting friends, which reduces their quality of life. Development of interventions for gait impairments and falls is a research priority for Parkinson's UK.\n\nUnderstanding gait Traditionally, one approach a physiotherapist may use to try and improve\u002Fretrain a person's gait is with an electronic metronome which is a device that \"beeps\" nearly every second. The physiotherapist sets the metronome beeping, and the person tries to step to each beep. However, success depends on the physio's expertise\u002Fexperience. Regardless, beeping sounds are described as boring.\n\nSmartphone app An app may be the solution. Smartphones have many sensors, meaning they can accurately measure gait but also deliver retraining via music. That is possible by the creation of an \"app\" that can be downloaded and installed on anyone's smartphone.\n\nResearch proposal The investigators have developed and validated an app (CuePD) that uses music for gait retraining, to make it more enjoyable by having people listen to their preferred music. The aim for this study is to get people with PD (PwPD) using CuePD in their home and when out walking for 12-weeks to determine: (i) how PwPD use and value CuePD and (ii) CuePD's ability to improve gait to reduce fall risk.",[28],[571,572,573],"Wearables","Personalised cueing","Gait retraining","2026-05-08",{"date":525,"type":43},{"date":129,"type":22},{"date":102,"type":22},{"name":579,"class":50},"Northumbria University",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":90,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":601,"locationsCount":81},"100482935","phase-2-probiotic-treatment-for-depression-and-associated-mood-disorders-in-parkinsons-disease-100482935","NCT05568498","Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease","ProD","Inclusion Criteria:\n\n1. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria\n2. Between the ages of 40-80 years\n3. Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the \"ON\" state)\n4. Mild to moderate depression (BDI-II score of 14-28 in the \"ON\" state)\n5. Women of childbearing potential must agree to use a medically approved method of birth control (e.g., hormonal contraceptives, intrauterine devices, vasectomy\u002Ftubal litigation, barrier methods and double barrier method) and must have negative pregnancy test results at screening and baseline\n6. Willingness to maintain current physical activity levels during study period\n7. English proficiency\n\nExclusion Criteria:\n\n1. Atypical Parkinsonism\n2. Active suicidality\n3. Active psychosis\n4. Cognitive score (MoCA) of \\\u003C 21 in the \"ON\" state\n5. Severe depression (BDI-II score \\> 28 in the \"ON\" state)\n6. Probiotic, Saccharomyces boulardii and\u002For antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)\n7. The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)\n8. Change in the schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks\n9. Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks\n10. Change in Parkinson's medication within the last 2 weeks\n11. Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumour, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma\n12. A significant immune-compromised condition due to either a health condition or use of an immune suppressant (e.g., AIDS, lymphoma, chemotherapy treatment, patients undergoing long-term systemic corticosteroid or immunosuppressant treatment)\n13. A known bleeding disorder\n14. Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)\n15. Allergy to corn starch or corn\n16. Concurrent treatment for Parkinson's disease with Duodopa\n17. Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks\n18. New onset of significant psychiatric symptoms following DBS procedure that are considered likely related\n19. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial\n20. Unstable medical conditions or serious disease\u002Fconditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)\n21. Drug and\u002For substance abuse\n22. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study. This includes any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a significant language barrier or cognitive impairment",{"count":588,"type":22},60,[146],"This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.",[179,592,28],"Depression",[151,592,594,595],"Probiotics","Gut Microbiome","2026-05-05",{"date":574,"type":43},{"date":599,"type":43},"2025-01-20",{"date":102,"type":22},{"name":602,"class":50},"University of British Columbia",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":88,"sex":17,"minAge":611,"maxAge":90,"enrollmentInfo":612,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":625,"leadSponsor":627,"locationsCount":51},"100636600","gbpdc-gut-brain-in-pd-consortium-master-protocol-100636600","NCT07567794","GBPDC: Gut-Brain in PD Consortium Master Protocol","Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol","GBPDC","Inclusion Criteria (All PD Cohorts)\n\n1. Aged ≥21 years old and ≤80 years old\n2. Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n3. Adequate visual, hearing, cognitive, and physical ability\n4. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a \"best estimate\" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee\n\nInclusion Criteria Controls\n\n1. Aged ≥21 years old and ≤80 years old\n2. No known or diagnosed neurodegenerative disease\n3. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n4. Resides within the same household as person with PD\n\nInclusion Criteria Prodromal Cohort\n\n1. Aged ≥21 years old and ≤80 years old\n2. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.\n\nExclusion Criteria (All Cohorts)\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Laboratory Values:\n\n   1. Hemoglobin (Hgb) \\\u003C10\n   2. Platelets \\\u003C70,000\n   3. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN)\n   4. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002FBSA \\[body surface area\\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \\[ALP\\] \\>2.0 times the ULN and\u002For total bilirubin \\>2.0 times the ULN)\n   5. Significantly above the normal range for PT\u002FINR\u002FPTT\n3. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure\n4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \\\u003C22\n5. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed\u002Ftreated vitamin B12 deficiency, or other screening laboratory abnormalities\n6. Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide\n7. Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated\u002Fremoved cutaneous carcinomas are not excluded.)\n8. Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study\n9. Body mass index (BMI) \\>35 kg\u002Fm2 or body weight \\\u003C50 kg\n10. Participant is currently pregnant, breastfeeding, and\u002For lactating\n11. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n12. History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n13. Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment\n14. Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.\n15. History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n16. Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n17. Has a history of Crohn's disease, ulcerative colitis, and\u002For other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and\u002For, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.","21 Years",{"count":613,"type":22},250,"The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.\n\nDuring this study, specific groups of participants, also known as \"cohorts\", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.\n\nParticipants in this study will:\n\n* meet with a medical provider\n* answer questionnaires\n* give samples of blood, stool, and saliva\n* have X-rays taken while swallowing different foods (swallowing study)\n* have X-rays taken to see how long it takes markers to move through their colon (colon transit study)\n* have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)\n* have samples taken of their skin\n* have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.\n\nParticipation in the study will last up to 24 months (2 years).",[172,28,595,616,617],"Gut Microbiota","Prodromal Parkinsons Disease",[619,521,620,621],"gut brain","Prodromal Parkinson's disease","healthy control","2026-04-29",{"date":596,"type":43},{"date":438,"type":22},{"date":626,"type":22},"2028-12-31",{"name":628,"class":50},"Duke University",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":240},"100616476","the-effect-of-long-term-daily-stimulation-of-the-brain-with-pulsed-electromagnetic-fields-on-parkinsons-disease-100616476","NCT07306104","The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease","The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF","Intervention Groups\n\nInclusion Criteria:\n\n* Diagnosed with idiopathic Parkinson's disease\n* The participant must be able to understand, accept, and complete the planned procedures\n* Parkinson's symptoms in the medicated state must correspond to Hoehn \\& Yahr stage 1 or 2\n* Mini Mental-State Examination score \\> 22\n\nExclusion Criteria:\n\n* Cancer in the brain, neck, or head area\n* Presence of active medical implants\n* Epilepsy\n* Alcoholism\n* Substance abuse\n* Open wound on the scalp\n* Severe psychopathological disorders\n* Pregnancy\n* Changes in pharmacological anti-Parkinson medication within the last 6 weeks prior to the start of T-PEMF treatment\n* Anticoagulant treatment with Marevan, Marcoumar, Pradaxa, Eliquis, Xarelto, Lixiana, Novostan, Fragmin, or Innohep\n* Neurological disease other than Parkinson's disease\n* Previous stroke\n* Reduced motor function caused by conditions other than Parkinson's disease\n\nControl Group with Parkinson's Disease\n\nInclusion Criteria:\n\n* Diagnosed with idiopathic Parkinson's disease\n* The patient must be able to understand, accept, and complete the planned procedures\n* Parkinson's symptoms in the medicated state must correspond to Hoehn \\& Yahr stage 1 or 2\n* Mini Mental-State Examination score \\> 22\n\nExclusion Criteria:\n\n* Neurological disease other than Parkinson's disease\n* Reduced motor function caused by conditions other than Parkinson's disease\n\nHealthy Reference Group:\n\nInclusion Criteria:\n\n-The patient must be able to understand, accept, and complete the planned procedures\n\nExclusion Criteria:\n\n* Neurological disease\n* Reduced motor function caused by condition",{"count":637,"type":22},90,[64],"The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson's Disease. The main questions it aims to answer are:\n\n* How does 6 months of daily treatment (30 minutes\u002Fday) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson's disease?\n* How does 12 months of daily treatment (30 minutes\u002Fday) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson's disease an does 12 months of T-PEMF alters the need for medication intake?\n\nThe neuro-mechanical outcomes are compared with the \"natural\" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake.\n\nParticipants in the intervention group will:\n\n* receive one 30 min treatment session daily for 12 months\n* receive either T-PEMF or sham treatment for the first 6 months\n* receive active T-PEMF treatment the last 6 months\n* visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.",[28],[642],"T-PEMF","2026-04-28",{"date":622,"type":43},{"date":646,"type":43},"2026-02-16",{"date":648,"type":22},"2028-01",{"name":650,"class":50},"University of Southern Denmark"]