[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinson-disease-pd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinson-disease-pd":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,50,0,25,[9,40,66,95,121,141,173,201,230,260,287,315,340,366,393,433,460,479,514,534,561,581,604,632,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100644659","probing-gut-brain-communication-in-parkinsons-disease-100644659",false,"NCT07673146","Probing Gut-Brain Communication in Parkinson's Disease","Inclusion Criteria:\n\n* Aged ≥21 years old and ≤80 years old\n* Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n* Adequate visual, hearing, cognitive, and physical ability\n\nExclusion Criteria:\n\n* Diagnosis of secondary or atypical parkinsonism\n* Laboratory Values: a: Hemoglobin (Hgb) \\\u003C10; b: Platelets \\\u003C70,000; c: Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN); d: 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); e: Significantly above the normal range for PT\u002FINR\u002FPTT.\n* Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score 35 kg\u002Fm2 or body weight\n* 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\n* 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\n* Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated cutaneous squamous or basal cell carcinomas are not excluded.)\n* 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\n* Body weight \\> 400lbs (limit of the MRI table)\n* Participant is currently pregnant, breastfeeding, and\u002For lactating\n* History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n* History of Covid-19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n* 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\n* 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.\n* History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n* Use of medications that impact the microbiota including antibiotics during the 4 weeks prior to enrollment\n* Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n* Endorses any contraindications to MRI (see risks section of protocol for full list of MRI exclusions)\n* Allergic to pineapple","ALL","21 Years","80 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"NA","Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity.",[27],"Parkinson Disease (PD)","NOT_YET_RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":21},"2026-08-01",{"date":36,"type":21},"2031-07-01",{"name":38,"class":39},"Spaulding Rehabilitation Hospital","OTHER",{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100601827","daily-amino-acid-supplementation-for-people-with-parkinsons-disease-100601827","NCT07115563","Daily Amino Acid Supplementation for People With Parkinson's Disease","Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers","Inclusionary Criteria:\n\n* Male and Females.\n* 50-80 Years.\n* Previous diagnosis of idiopathic Parkinson's Disease by patient report.\n* Use of dopamine replacement medication (e.g. levodopa) for at least 2 years.\n* On a stable dose of dopamine replacement medication for at least 3 months with no plans for change in the next two months.\n\nExclusionary criteria\n\n* Apparent cognitive impairment as determined by phone screening (Telephone Interview for Cognitive Status \\\u003C29).\n* Diagnosis of Parkinsonism or atypical Parkinson's Disease.\n* Prescription of Dopamine antagonist.\n* Any unstable medical condition.\n* Use of Deep Brain Stimulation.\n* Gastric or Bowel resection surgery.\n* Contraindications to blood draw.","50 Years",{"count":49,"type":21},30,[24],"The goal of this clinical trial is to learn if a tailored amino acid supplement works to help adults living with Parkinson's disease to improve nutrition, metabolic function, body composition, and physical and mental function. The main questions it aims to answer are:\n\nDoes the tailored amino acid supplement increase essential amino acids (nutritional status)?\n\nDoes the tailored amino acid supplement increase an antioxidant (complex amino acid) and decrease an amino acid associated with oxidative stress?\n\nDoes the tailored amino acid supplement improve physical and mental health compared to a placebo supplement?\n\nResearchers will compare the tailored amino acid supplement to a placebo (a look-alike substance that contains no active ingredients) to see if the tailored amino acid supplements work to support health for people with Parkinson's disease.\n\nParticipants will:\n\nTake the tailored amino acid supplement or a placebo every day for 6 months, visit the lab at baseline, after 3 months, and after 6 months for fasting blood draws, body composition assessment, and physical and mental health testing and keep a diary of their food intake and supplement intake.",[27],[54,55,56],"Nutrition","Parkinson&#39;s disease","Amino acid supplements","RECRUITING",{"date":31,"type":32},{"date":60,"type":32},"2025-10-31",{"date":62,"type":21},"2027-11",{"name":64,"class":39},"Cristina Colon-Semenza",1,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":16,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":65},"100645245","the-effect-of-bottle-pep-exercise-on-expiratory-muscle-thickness-strength-and-balance-parameters-in-parkinsons-disease-patients-100645245","NCT07680725","The Effect of Bottle PEP Exercise on Expiratory Muscle Thickness, Strength, and Balance Parameters in Parkinson's Disease Patients","Inclusion Criteria:\n\n* Patients with a confirmed Parkinson's diagnosis who are being monitored\n* Those aged 18-75\n* Patients who are ambulatory\n\nExclusion Criteria:\n\n* Patients with acquired primary motor neuron disease (ischemic\u002Fhemorrhagic stroke, intracranial mass) and additional neurological diagnoses\n* Patients with hearing and cognitive impairments that prevent them from understanding or performing the exercise program\n* Presence of concomitant acute or chronic lung disease\n* History of thoracic or abdominal surgery\n* Severe heart disease\n* Active cancer\n* Mini-Mental State Examination (MMSE) score ≤ 24\n* Active smoking","18 Years","75 Years",{"count":75,"type":21},42,"OBSERVATIONAL","Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, tremor, postural instability, bradykinesia, and autonomic dysfunction. It is a common movement disorder worldwide. Motor impairments in PD patients are not limited to the muscles of the extremities; the neck, upper respiratory tract, and respiratory muscles are also affected. The resulting pulmonary dysfunction is one of the main factors contributing to morbidity and mortality in PD patients.\n\nRespiratory muscle exercise programs have been used to improve lung and swallowing function in patients with Parkinson's disease and other similar neurodegenerative disorders. Studies of inspiratory muscle exercise in Parkinson's patients have reported improvements in inspiratory muscle strength and endurance. Similarly, expiratory muscle exercise protocols have been shown to increase maximum expiratory pressure (MEP) and cough effectiveness. However, studies on expiratory muscle strengthening are lacking in the literature.\n\nPositive expiratory pressure (PEP) devices are used to clear airway secretions and feature a resistance that provides resistance during exhalation. This creates a positive pressure that stabilizes the airways during exhalation and prevents airway collapse. Although there are many PEP devices available on the market, the bottle-PEP, a therapist-made device, is used because it can be produced easily and at low cost. The bottle-PEP device consists of a bottle filled with at least 10 cm of water and a tube placed inside the bottle. Although information on strengthening expiratory muscles is traditionally found in the literature, there is no data in the literature on the effect of bottle-PEP use on expiratory muscle strength, especially in Parkinson's patients. A review of the literature shows that the effect of expiratory strengthening on balance has not been studied before.\n\nThis study aimed to demonstrate the effects of the bottle-PEP device, used in addition to expiratory muscle strengthening, on expiratory muscle thickness, strength, and balance.",[27],[80,81,82,83,84,85,86],"Parkinson","Parkinson disease","diaphragm thickness","inspiratory muscle","respiratory exercises","bottle-PEP","balance","2026-06-29",{"date":31,"type":32},{"date":90,"type":32},"2025-10-01",{"date":92,"type":21},"2026-11-01",{"name":94,"class":39},"Marmara University",{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":16,"minAge":72,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":65},"100606494","phase-2-18f-mfbg-cardiac-uptake-with-lewy-body-dementia-100606494","NCT07176286","18F-mFBG Cardiac Uptake With Lewy Body Dementia","An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases","IRP101-231","Inclusion Criteria:\n\n* 1\\. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.\n\n  3\\. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and\u002For hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.\n\n  4\\. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.\n\nFor Lewy body disease subjects (Study Cohort I):\n\n5\\. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.\n\nFor non-Lewy body disease subjects (Study Cohort II):\n\n6\\. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.\n\nExclusion Criteria:\n\n* 1\\. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.\n\n  2\\. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.\n\n  3\\. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.\n\n  4\\. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.\n\n  5\\. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.\n\n  6\\. The subject is claustrophobic or has a movement disorder that prevents him\u002Fher from lying still in a supine position for up to 20 minutes.\n\n  7\\. Renal insufficiency (serum creatinine \\>3.0 mg\u002FdL). 8. Uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.\n\n  9\\. Participated in a research study using ionizing radiation in the previous 12 months such that participation in the study might result in a total effective dose from research procedures exceeding 50 milliSieverts during that time interval.",{"count":104,"type":21},20,[106],"PHASE2","This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.",[27,109],"Lewy Body Dementia (LBD)",[101,111],"18F-mFBG",{"date":113,"type":32},"2026-07-01",{"date":115,"type":32},"2026-04-30",{"date":117,"type":21},"2026-12-30",{"name":119,"class":120},"Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)","INDUSTRY",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":16,"minAge":72,"maxAge":73,"enrollmentInfo":129,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100644798","outlining-biological-effects-of-subthalamic-deep-brain-stimulation-in-parkinsons-disease-patients-100644798","NCT07673783","Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients.","Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes","BRAIN-DBS-GAIN","Inclusion Criteria:\n\n* clinically established diagnosis of PD according to the criteria of the Movement Disorder Society (MDS) (Postuma et al., Mov Disord 2015);\n* a minimum disease duration of 4 years;\n* eligibility for STN-DBS surgery according to Core Assessment Program for Surgical Interventional Therapies in PD (Defer et al., Mov Disord 1999);\n* age between 18 and 75 years.\n\nExclusion Criteria:\n\n* inability to express an informed consent;\n* moderate or severe cognitive impairment (score \\\u003C 24 on the Mini-Mental State Examination);\n* severe psychiatric symptoms (e.g., psychosis, major depression);\n* previous neurosurgical interventions for PD;\n* pregnancy;\n* ongoing inflammatory or autoimmune diseases;\n* chronic infectious diseases;\n* active neoplasms;\n* chronic intake of anti-inflammatory drugs (e.g. steroids or NSAIDs).",{"count":130,"type":21},90,"The aim of the study is to characterize the neuroinflammatory effects of subthalamic deep brain stimulation in patients with Parkinson's disease, by analyzing changes in blood neuroinflammatory and neurodegenerative biomarkers before and after surgery (at 6 and 12 months, respectively), and comparing the changes in blood biomarkers levels with a control group of patients with advanced PD on best medical treatment.",[27],"2026-06-23",{"date":87,"type":32},{"date":136,"type":21},"2026-09-01",{"date":138,"type":21},"2028-02-29",{"name":140,"class":39},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":16,"minAge":148,"maxAge":18,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":160,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"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.","40 Years",{"count":150,"type":21},34,[24],"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.",[154,27,155,156,157,158,159],"PARKINSON DISEASE (Disorder)","Parkinson s Disease","Postural Instability","Postural Instability Gait Disorders","Gait Disorders","Cognitive Dysfunction, Cognitive Disorder",[161,156,158,162,163,164],"Parkinson Disease","Cognitive Dysfunction","Dual Task","Virtual Reality",{"date":166,"type":32},"2026-06-25",{"date":168,"type":21},"2026-06-20",{"date":170,"type":21},"2027-12-30",{"name":172,"class":39},"Bezmialem Vakif University",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":65},"100641859","passive-versus-active-music-therapy-parkinsons-disease-100641859","NCT07661524","Passive Versus Active Music Therapy Parkinson's Disease","Effects of Active Versus Passive Music Therapy on Functional Ability and Psychophysiological Responses to Goal-Directed Exercise in People With Parkinson's Disease","Inclusion Criteria:\n\n* Formal diagnosis of idiopathic PD\n* Hoen \\& Yahr Stage \\\u003CIII\n* Middle or old age onset of PD (at least 50 years of age)\n* The ability to ambulate without assistive devices\n* Stable medication regimen for four weeks prior to participation\n* No changes to treatment of PD in the last month.\n\nExclusion Criteria:\n\n* Primary psychiatric disease (non-PD related)\n* Reports of falling in the last six weeks\n* Any reason a participant or their healthcare team believed their participation in the study could negatively impact their well-being.","89 Years",{"count":182,"type":21},28,[24],"The purpose of this pilot study is to identify the effects of active versus passive music therapy on functional ability and psychophysiological responses to goal-directed exercise in people with Parkinson's disease.",[27],[187,188,189,190,191],"Music therapy","Exercise","Motivation","Parkinson's","Neurodegeneration","2026-06-16",{"date":194,"type":32},"2026-06-22",{"date":196,"type":21},"2026-08",{"date":198,"type":21},"2027-08",{"name":200,"class":39},"University of Alabama at Birmingham",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":16,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":229},"100636929","phase-1-safety-and-feasibility-of-bilateral-striatal-transplantation-of-dopacell-in-parkinsons-disease-100636929","NCT07572071","Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease","Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial","Inclusion Criteria:\n\n* Age: 30-70 years\n* Diagnosis of PD: MDS clinical Diagnostic Criteria for Parkinson's disease\n* The disease duration more than 5 years\n* Moderate Parkinson's disease, defined as a Hoehn and Yahr stage of 2 or 3 during the OFF period.\n* The patient is receiving oral pharmacological therapy, and in the opinion of the Principal Investigator, the patient's symptoms remain inadequately controlled despite optimal medical management, or the patient is experiencing adverse effects related to their current treatment\n* No history or only mild levodopa-induced dyskinesia, defined as a score of 2 or less on the UDysRS scale in any body region during the ON state.\n* The patient demonstrates a clinically meaningful response to a therapeutic dose of levodopa, as determined by the Principal Clinical Investigator or a trained specialist under the supervision of the Principal Investigator.\n* The performance of different organs based on laboratory evaluations:\n\n  * Number of neutrophils ≥2000 \u002F microliter\n  * Platelet count ≥100,000 \u002F microliter\n  * AST \u002F ALT: less than or equal to three times the maximum normal value at the intervention site\n  * Total bilirubin less than or equal to 1.5 times the maximum normal amount at the intervention site\n  * eGFR \\* rate: greater than or equal to 60 ml \u002F min \u002F 1.73 m2 \\* eGFR (mL \u002F min \u002F 1.73 m2) = 194 X Cr \\^ -1.094 X age \\^ -0.287 (X 0.739 for females)\n* Informed consent\n\nExclusion Criteria:\n\n* The abnormal function of immune system\n* The symptomatic brain injuries (brain atrophy, cerebral Infarct, trauma, vascular malformation) confirmed by brain MRI\n* Markedly reduced or normal signal in the ventral striatum on TRO-DaT SPECT imaging.\n* Any abnormal findings on brain MRI.\n* Positive GBA mutation test.\n* Diagnosis of dementia based on a MoCA score \\\u003C 24.\n* The abnormality of thrombotic system or high risk of bleeding\n* Positive for any of the following viral markers or active infections: HBsAg, HBsAb, HBcAb, anti-HIV antibodies, anti-HTLV-1\\&2 antibodies, active hepatitis C infection, syphilis, or active CMV, VZV, EBV, or COVID-19 infection.\n* Impossibility of MRI imaging for patients with metal in the body, pacemaker in the body, claustrophobia, with artificial heart valves that are incompatible with MRI or body weight is not within the tolerable range for MRI.\n* Patients with contraindications to the study drug: Tacrolimus, Prednisolone, Basiliximab, Cotrimoxazole, MRI contrast agent.\n* Patients undergoing other cell transplants, including embryonic stem cell-derived dopaminergic progenitor cells.\n* Patients with a history of PD at the same time and concurrent: Malignant neoplasm, epilepsy, cerebral hemorrhage or a positive history\n* Psychiatric disorders confirmed by a psychiatrist, including major depression, bipolar disorder, or schizophrenia, that are uncontrolled or treatment resistant.\n* Patients with intellectual disability who, in the judgment of a psychiatrist, are unable to fully comprehend the study requirements.\n* History of pallidotomy, thalamotomy, or deep brain stimulation (DBS).\n* Patients considered high-risk candidates for surgery, particularly neurosurgery or DBS implantation, due to significant cardiovascular, pulmonary, or other systemic comorbidities identified during preoperative evaluation.\n* Patients who have a history of taking the following in the three months prior to enrollment: Immunosuppressant, antipsychotic drug, anticonvulsant drugs or anticoagulant therapy (if discontinuation or perioperative adjustment is not feasible), botulinum toxin (within 6 months), phenol injections, or other treatments for dystonia or muscle spasm\n* History of Apomorphine use\n* History of chronic alcohol use or illicit drug abuse.\n* Patients who are pregnant, lactating, or people who did not avoid pregnancy during the study.\n* Patients who, according to the researchers' opinions, are not suitable for safe study.","30 Years","70 Years",{"count":211,"type":21},6,[213],"PHASE1","Dopason is a phase I, open-label, multicenter, single-arm clinical trial designed to evaluate the safety and feasibility of intraputaminal transplantation of human embryonic stem cell-derived dopaminergic progenitor cells (DopaCells) in patients with moderately severe Parkinson's disease.",[27],[217,218,219],"Parkinson's disease","Dopaminergic progenitor cell transplantation","Intrastriatal",{"date":221,"type":32},"2026-06-18",{"date":223,"type":32},"2025-08-01",{"date":225,"type":21},"2030-08-01",{"name":227,"class":228},"Royan Institute","OTHER_GOV",3,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":238,"sex":16,"minAge":47,"maxAge":73,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100643640","early-phase-1-test-retest-trial-with-11cmodag-005-in-pd-or-msa-and-amhc---pilot-phase-100643640","NCT07640542","Test-retest Trial With [11C]MODAG-005 in PD or MSA and AMHC - Pilot Phase","An Open-label, Single-center Study to Evaluate the Safety and Test-retest Characteristics of [11C]MODAG-005 as PET Radioligand for Imaging Pathological Alpha-synuclein Deposition in the Brains of Patients With Parkinson's Disease (PD) or Multiple System Atrophy (MSA) Compared to Age-matched Healthy Controls (AMHC) - Pilot Phase","PIOSA","Inclusion Criteria:\n\n* Key inclusion criteria: Patients with MSA fulfilling both the criteria for probable MSA (Gilman et al., 2008) and clinically established MSA (Wenning et al., 2022), patients with PD fulfilling the criteria for clinically established PD (Postuma et al., 2015) or age-matched healthy controls (AMHC).\n\nExclusion Criteria:\n\n1. Laboratory tests with clinically significant abnormalities and\u002For clinically significant unstable medical illness equivalent to CTC v5.0 (common toxicity criteria) toxicities greater than grade 2.\n2. Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the trial procedures as judged by the investigator.\n3. Clinically significant renal and hepatic dysfunction as judged by the investigator.\n4. Known hypersensitivity to the active substance or to any of the excipients of \\[11C\\]MODAG-005 solution for injection.\n5. Known hypersensitivity to the active substance or to any of the excipients in anle138b (Emrusolmin) capsules.\n6. Participant has received an investigational drug within 3 months of screening.\n7. Blood donations within 7 days before enrolment.\n8. Pregnant (see 9.1.5) or breast-feeding or having the intention of getting pregnant. Female participants of childbearing potential and male participants with female partners of childbearing potential not willing to practice effective contraception during the trial period and for 90 days following each PET\u002FCT scan.\n9. Unsuitable veins for repeated venipuncture.\n10. Contraindication to blood sampling and\u002For arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test on both arms or abnormal coagulation profile at screening. If Allen's test should be \"abnormal\" on both arms, the participant will not be eligible for arterial sampling, but will participate in the remaining assessments.\n11. MRI exclusion criteria include but not limited to: findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct \\>1 cm\\^3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid-Attenuated Inversion Recov ery (FLAIR) sequence that is \\>20 mm in any dimension), infectious disease, space-occupying lesions normal pressure hydrocephalus or any other abnormalities associated with central nervous system (CNS) disease. Findings that are expected to be present in the PD and MSA participants (e.g. absence of swallow tail sign, presence of regional atrophy or hot cross bun sign) do not lead to exclusion of these participants.\n12. Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.\n13. Unwilling and\u002For unable to cooperate with trial procedures.\n\n    Exclusion criteria for age-matched healthy controls:\n14. Relevant hepatic parameters above upper limit of normal (ULN), i.e., glutamic pyruvic transaminase (GPT), glutamic oxaloacetic transaminase (GOT), bilirubin\n15. Relevant renal parameters outside normal limits, i.e., serum creatinine and blood urea nitrogen (BUN) above ULN; urinary albumin-creatinine ratio (uACR) below lower limit of normal (LLN)\n16. Systolic blood pressure \\\u003C90 or \\>140 mmHg; diastolic blood pressure \\\u003C45 or \\>90 mmHg; heart rate \\\u003C50 or \\>95 beats per minute (BPM)",true,{"count":240,"type":21},9,[242],"EARLY_PHASE1","This is an open-label, single-center Phase 1 study evaluating the safety, tolerability, and test-retest characteristics of \\[11C\\]MODAG-005, an investigational positron emission tomography\u002Fcomputed tomography (PET\u002FCT) radioligand intended to image pathological alpha-synuclein deposition in the brain. The study will enroll participants with Parkinson's disease (PD), participants with multiple system atrophy (MSA), and age-matched healthy controls (AMHC).\n\nParticipants with PD or MSA will undergo two \\[11C\\]MODAG-005 PET\u002FCT imaging sessions: one baseline scan and one follow-up scan 7 to 48 days later. Age-matched healthy controls will undergo one baseline scan. A subset of PD and MSA participants will receive a single oral dose of anle138b (Emrusolmin) before the second scan to evaluate tracer uptake under blocking conditions. The primary objective is to assess the safety and tolerability of \\[11C\\]MODAG-005. Secondary objectives include evaluating whether \\[11C\\]MODAG-005 PET imaging can distinguish participants with MSA or PD from age-matched healthy controls, distinguish PD from MSA, and determine test-retest variability of PET outcome measures.",[27,245,246],"MSA - Multiple System Atrophy","Healthy Adult Participants",[248,249,250,191,251],"MODAG","MODAG GmbH","Synuclein","Lewy Body","2026-06-06",{"date":254,"type":32},"2026-06-10",{"date":256,"type":21},"2026-06",{"date":258,"type":21},"2027-07",{"name":249,"class":120},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":16,"minAge":148,"maxAge":18,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100616937","phase-2-d-spark-a-clinical-trial-of-d-serine-for-modifying-parkinsons-disease-progression-100616937","NCT07312110","D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression","D-SPARK: A Randomized Double Blind Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression","D-SPARK","Inclusion Criteria:\n\n* A clinical diagnosis of PD\\* according to the clinically established MDS clinical diagnostic criteria for Parkinson's disease within 5 years.\n* \\[¹²³I\\]FP-CIT single photon emission CT (DaTscan) confirming dopaminergic nigrostriatal denervation.\n* Hoehn and Yahr score \\\u003C 3 at enrollment.\n* Optimal symptomatic PD treatment, not requiring adjustments, for at least 2 weeks.\n* Age ≥40 and ≤ 80 years at time of enrollment.\n\nExclusion Criteria:\n\n* Dementia or neurodegenerative disorder other than PD at baseline visit.\n* Atypical parkinsonism (PSP, MSA, CBD vascular parkinsonism, or drug induced parkinsonism).\n* Any known monogenic cause of PD (GBA1 variation is accepted).\n* Any psychiatric disorder that would interfere with compliance in the study.\n* Any severe somatic illness that would make the individual unable to comply and participate in the study.\n* Use of D-serine supplementation within 90 days of enrolment.\n* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.\n* Active of planned pregnancy during trial period.\n* Cognitive impairment as measured by the Mini Mental Status Exam MMSE) \\\u003C 20.\n* Weight \\\u003C 45 kg.\n* Urinary albumin\u002Fcreatinine ratio ≥ 20 mg\u002Fmmol at time of enrollment.\n* Participants will be excluded if they have CKD stage 3 or higher, defined as:\n\n  * Estimated golumerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73min\\^2 at screening, calculated using the CKD-EPI 2021 creatinine equation.",{"count":269,"type":21},100,[106],"This clinical study, designed as a randomized, double-blind, placebo-controlled trial, aims to investigate if modulation of the N-methyl-D-aspartate receptor (NMDAR) via its co-agonist D-serine has therapeutic benefits in Parkinson's disease (PD). All patients will receive both placebo and D-serine over different time periods during the study.\n\nPreclinical studies have shown that blocking glycine transporters, which elevates endogenous glycine levels, can restore NMDAR function and improve motor deficits in PD models. A clinical trial demonstrated that oral D-serine (30 mg\u002Fkg\u002Fday for 6 weeks) significantly reduced extrapyramidal and abnormal involuntary movements in PD patients compared to placebo, with improvements observed in both motor and non-motor symptoms. D-serine supplementation has shown an acceptable safety profile with doses up to 120 mg\u002Fkg showing no significant adverse effects in clinical studies.\n\nThe D-SPARK trial primarily aims to determine the efficacy of D-serine supplementation on clinical severity of PD as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).\n\nSecondary aims are to determine the efficacy of D-serine supplementation on improving dopaminergic nigrostriatal innervation as measured by single-photon emission tomography (SPECT) based imaging of the dopamine transporter (DaT-scan) and cognition as measured by the California Verbal Learning Test version 2 (CLVT-II).\n\nThe study will include 100 persons with Parkinson's disease (PwPD) diagnosed no longer than 5 years before baseline. Participants will be randomly assigned to receive D-Serine 4000 mg daily or placebo for defined periods of time during a 58 week treatment period, followed by a 12 week washout period.\n\nParticipants will undergo:\n\n* Clinical evaluations, including clinical rating scales and questionnaires.\n* Cognitive assessments.\n* Bio sampling of whole blood and blood plasma.\n* Single-photon emission tomography (SPECT) imaging of dopamine transporter levels (DaT-scan)\n\nThe outcomes of this study could potentially demonstrate that D-serine reduces symptom severity in Parkinson's disease and\u002For has an impact on the clinical trajectory of Parkinson's disease, benefiting persons living with Parkinson's disease, their families and society as a whole.",[155,27],[274,275,276],"Serine","Parkinsons disease","D-serine","2026-06-03",{"date":279,"type":32},"2026-06-04",{"date":281,"type":32},"2026-01-20",{"date":283,"type":21},"2028-12",{"name":285,"class":39},"Haukeland University Hospital",11,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":313,"locationsCount":65},"100562426","behavioral-intervention-for-lifestyle-physical-activity-in-parkinsons-disease-100562426","NCT06603012","Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease","LifePD","Inclusion Criteria:\n\n* confirmed diagnosis of PD\n* Internet and email access\n* willingness to complete the cognitive assessments and questionnaires, wear the accelerometer, and undergo randomization\n* insufficient physical activity (i.e., not meeting current physical activity guidelines) based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire\n* self-reported ability to ambulate without assistance\n* age of 50+ years\n* English as a primary language\n* asymptomatic (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire \\[PAR-Q\\]) or physician approval for undertaking exercise training for those with 2 or more affirmatives on the PAR-Q\n\nExclusion Criteria:\n\n* above inclusion criteria not met\n* moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q\n* severe cognitive impairment that might preclude compliance with the conditions based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18\n* normal cognitive impairment based on the Montreal Cognitive Assessment (MoCA) score of 26 or more for avoiding ceiling effects involving change in cognitive function",{"count":5,"type":21},[24],"The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\\&amp;#39;s home\u002Fcommunity and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.",[27],[81,299,300,301,302,303,304,305,306,307,188,308],"Parkinsonian disorders","Movement disorders","Basal ganglia diseases","Brain diseases","Nervous system diseases","Central nervous system diseases","Neurodegenerative diseases","Cognition","Walking","Physical Activity","2026-06-02",{"date":279,"type":32},{"date":196,"type":21},{"date":198,"type":21},{"name":314,"class":39},"University of Illinois at Chicago",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":16,"minAge":148,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":338,"locationsCount":65},"100634196","effects-of-dual-task-training-on-upper-extremity-function-in-parkinsons-disease-100634196","NCT07536542","Effects of Dual-Task Training on Upper Extremity Function in Parkinson's Disease","Effects of Dual-Task Training on Upper Extremity Function and Muscle Thickness in Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist\n* Modified Hoehn and Yahr stage 2 to 3\n* No medication or dosage change within the last 6 months\n* Cognitive capacity sufficient to understand and follow instructions, defined as Montreal Cognitive Assessment score ≥21\n* Voluntary participation with written informed consent\n\nExclusion Criteria:\n\n* Atypical or secondary parkinsonism\n* Advanced orthopedic condition affecting the upper extremity\n* Surgery, trauma, or immobilization involving the upper extremity within the last 6 months\n* Wound or dermatological condition preventing upper extremity ultrasonographic evaluation\n* Severe visual or hearing loss\n* Severe depression, psychosis, or communication difficulty\n* Any additional health problem preventing regular participation in the study","65 Years",{"count":324,"type":21},38,[24],"The goal of this clinical trial is to investigate the effects of dual-task training on upper extremity function and muscle thickness in individuals with Parkinson's disease. The main questions it aims to answer are:\n\nDoes dual-task training improve upper extremity function in individuals with Parkinson's disease? Does dual-task training lead to changes in upper extremity muscle thickness measured by ultrasonography?\n\nResearchers will compare a dual-task training group with a control group receiving routine care to determine whether 8 weeks of dual-task training results in greater improvements in upper extremity outco\n\nParticipants will:\n\ncomplete baseline and post-intervention assessments of upper extremity function, muscle thickness, grip strength, and pinch strength be assigned to either a control group or a dual-task training group receive dual-task training 3 days per week for 8 weeks if assigned to the intervention group",[27],[161,329,330,331,332],"Dual-Task Training","Upper Extremity Function","Muscle Thickness","Ultrasonography","2026-05-31",{"date":309,"type":32},{"date":336,"type":32},"2026-04-24",{"date":34,"type":21},{"name":339,"class":39},"Ankara University",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":347,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":361,"leadSponsor":363,"locationsCount":65},"100638226","phase-4-pilot-deprescribing-of-antimuscarinic-overactive-bladder-medications-in-parkinson-disease-100638226","NCT07627529","Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease","Evaluating the Effect of Deprescribing Antimuscarinic Overactive Bladder Medications on Cognitive Function and Quality of Life of Individuals With Parkinson Disease: A Pharmacist-led Series of N-of-1 Trials","Inclusion Criteria:\n\n1. 60+ years old at time of enrollment\n2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist\n3. Life expectancy of at least six months\n4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months\n5. Are able to provide informed consent\n6. Are able to complete online surveys\u002Fquestionnaires\n7. Are able to receive telephone calls and Zoom calls\u002Ftelehealth meeting\n\nExclusion Criteria:\n\n1. Have untreated or uncontrolled hypertension (blood pressure \\[BP\\] ≥180\u002F110 mmHg),\n2. Have active urinary tract infection (UTI) or chronic\u002Frecurrent UTI (≥2 UTIs in six months or ≥3 in one year)\n3. Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C)\n4. Have severe renal impairment (Estimated Glomerular Filtration Rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.72 m2) or end-stage renal disease (on dialysis or renal replacement therapy)\n5. Have prior history of hypersensitivity or intolerance to mirabegron or vibegron\n6. Have existing cognitive impairment (Montreal Cognitive Assessment \\[MoCA\\] score \\\u003C22\u002F30) or psychiatric disorder that preclude informed consent\n7. Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation\n8. On non-oral form of OAB antimuscarinics, the oral solution formulation of oxybutynin chloride or the oral suspension formulation of solifenacin succinate (due to complicated tapering process)","60 Years",{"count":104,"type":21},[350],"PHASE4","This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration\u002Freversal design (\"ON\" \\[A\\] vs. \"OFF\" \\[B\\]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the \"OFF\" \\[B\\] period, with the goal to completely discontinue the medication.",[27],[81,354,355,356,357,358],"overactive bladder","antimuscarinic","deprescribing","cognitive function","quality of life",{"date":279,"type":32},{"date":256,"type":21},{"date":362,"type":21},"2027-04",{"name":364,"class":365},"Corporal Michael J. Crescenz VA Medical Center","FED",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":16,"minAge":208,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":381,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":65},"100639450","developing-precision-microbiota-based-cocktail-modification-therapy-to-delay-the-progression-of-parkinsons-disease-pd---use-preclinical-human-trials-to-confirm-the-impact-of-the-optimal-probiotic-y7-tryptophan-and-branched-chain-amino-acid-cocktail-formula-on-early-stage-pd-patients-100639450","NCT07619560","Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease (PD) - Use Preclinical Human Trials to Confirm the Impact of the Optimal \"Probiotic Y7, Tryptophan and Branched-chain Amino Acid\" Cocktail Formula on Early Stage PD Patients","Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal \"Probiotic Y7, Tryptophan and Branched-chain Amino Acid\" Cocktail Formula on Early Stage Parkinson's Disease Patient","Inclusion Criteria:\n\nSubject Inclusion Criteria:\n\n1. Age between 30-85 years old.\n2. Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr scale stage 1-3).\n3. Brain MRI confirms striatal degeneration in the basal ganglia region, with no history of stroke.\n4. Responds to Parkinson's disease-related medications (e.g., Levodopa).\n5. Free of any major or acute illnesses.\n6. Able to comply with the 12 weeks intervention and required assessments for the study.\n\nExclusion Criteria:\n\n1. Unable to complete interviews or has mobility issues.\n2. Presence of major or acute illness before or during the study.\n3. Co-existing intestinal co-infections, such as CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus.\n4. Allergic to the intervention product.\n5. Pregnant or breastfeeding women.","85 Years",{"count":375,"type":21},120,[24],"Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. The study aims to recruit 120 patients (stage 1-3) and employ a two-arm, randomized controlled trial (RCT) design, dividing subjects into intervention and control groups for a 12 weeks trial period. Commercial development will be contingent upon the clinical trial outcomes, evaluating whether the product offers clinical benefits such as delaying Parkinson's disease progression in motor, cognitive, and non-motor functions. Additionally, a personalized and precise prognosis prediction model for Parkinson's disease will be established. This model will gather comprehensive clinical data, including motor function assessments (functional tests, UPDRS), biochemical markers, questionnaire responses, and genotype data (TPM array), as well as metabolite and microbial data. Through integrated analysis of this biological information using machine learning techniques, a personalized and accurate prognosis prediction model for Parkinson's disease will be developed. This model will predict the disease status of PD patients 12 weeks later, accounting for factors such as cocktail therapy. The results will empower PD patients to understand their individual disease progression and treatment prognosis, enabling them to prepare accordingly. Moreover, this model will aid researchers in identifying patient profiles more likely to benefit from treatment, thereby enhancing the evaluation of the efficacy and applicability of cocktail therapy.",[27,379,380],"Gut Microbiota","Probiotic",[382,383,384],"Parkinson's Disease","Probiotics","Gut microbiota","2026-05-24",{"date":309,"type":32},{"date":388,"type":32},"2025-05-20",{"date":390,"type":21},"2027-08-31",{"name":392,"class":39},"Taipei Medical University",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":65},"100640586","effects-of-transcutaneous-vagus-nerve-stimulation-in-parkinsons-disease-100640586","NCT07588191","Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease","Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease","tVNS_PD","Inclusion Criteria:\n\n* Being a member of the Association or be interested in joining;\n* Idiopathic PD diagnosis, stages 2-3 according to the Hoehn \\& Yahr scale; confirmed by neurologist\n* Ability to walk independently for at least 1 minute ant turn 180° without assistance;\n* Exhibiting symptoms of hypokinetic dysarthria;\n* On stable dopaminergic therapy for at least 1 month prior to the experiment\n\nExclusion Criteria:\n\n* Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)\n* Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)\n* Voice or speech disorders caused by other medical conditions\n* MoCA score below 21\n* Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness\n* Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg\n* Inability to attend sessions;\n* Concomitant neurological, orthopaedic, cardiac, respiratory or active medical\u002Foncological condition that would affect participation",{"count":402,"type":21},46,[24],"This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application sites.\n\nEach subject will undergo an initial in-person screening and provide consent before participating in the study.\n\nThe main questions to answer are:\n\n* Does transcutaneous electrical nerve stimulation (tVNS) in the ear paired with physical and speech therapy improve speech and voice-related problems, airway protection, salivation, and swallowing?\n* Does tVNS paired with physical and speech therapy improve tremor, walking speed, and balance in people with PD?\n* Does tVNS paired with physical and speech therapy improve heart rate and heart rate variability in people with PD?\n* Do its effects persist at 8 weeks?\n\nParticipants will:\n\nAttend 12 rehabilitation sessions over 4 weeks (three per week). During each session, participants received either active or sham tVNS, accompanied by speech therapy (once per week), physical therapy (once per week), or conducted alone (once per week).\n\nUndergo speech, voice, swallowing, respiratory, gait, balance, tremor, heart rate variability, and cognitive testing, as well as questionnaires regarding the quality of life, before and after treatment.\n\nReturn for a follow-up visit eight weeks after therapy to check how long the effects last.",[406,27],"Transcutaneous Vagal Nerve Stimulation (tVNS)",[408,409,161,410,411,412,413,414,415,416,417,418,419,420,421,422,423],"transcutaneous electrical nerve stimulation","Vagus Nerve","Speech Therapy","Physical Therapy Modalities","Deglutition","Tremor","Posture","Gait","Quality of Life","cognition","cough","Sialorrhea","Xerostomia","Heart Rate","voice disorders","Ear","2026-05-15",{"date":426,"type":32},"2026-05-19",{"date":428,"type":21},"2026-05",{"date":430,"type":21},"2026-11",{"name":432,"class":39},"Universidade da Coruña",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":16,"minAge":148,"maxAge":18,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":65},"100640932","robot-assisted-gait-training-vs-nmes-in-parkinsons-disease-100640932","NCT07589296","Robot-Assisted Gait Training vs NMES in Parkinson's Disease","Comparative Effects of Robot-Assisted Gait Training and Quadriceps Neuromuscular Electrical Stimulation Added to Standard Exercise Rehabilitation on Balance, Gait, Disease Severity, and Quadriceps Muscle Adaptations in Patients With Parkinson Disease: A Prospective Randomized Assessor-Blinded Clinical Trial","ROBO-NMES-PD","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to established clinical criteria\n* Age between 40 and 80 years\n* Hoehn and Yahr stage II-III\n* Ability to walk independently with or without assistive devices\n* Stable medical treatment for at least 4 weeks prior to study enrollment\n* Ability to understand and follow instructions\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Severe cognitive impairment or inability to follow instructions\n* Hoehn and Yahr stage IV-V Parkinson's disease\n* Severe musculoskeletal disorders affecting gait (e.g., advanced osteoarthritis, recent fracture)\n* History of lower extremity surgery within the last 6 months\n* Severe cardiovascular or respiratory disease limiting exercise participation\n* Presence of other neurological disorders affecting mobility (e.g., stroke, multiple sclerosis)\n* Contraindications to electrical stimulation (e.g., pacemaker, implanted electronic devices)\n* Skin lesions or infections at electrode placement sites\n* Participation in another structured rehabilitation program within the last 3 months",{"count":442,"type":21},40,[24],"This prospective, randomized, assessor-blinded clinical trial aims to compare the effects of robot-assisted gait training and quadriceps neuromuscular electrical stimulation (NMES) when added to a standard exercise rehabilitation program in patients with Parkinson disease.\n\nParticipants will be randomly assigned to two parallel groups. Both groups will receive a standard rehabilitation program, while one group will additionally undergo robot-assisted gait training and the other group will receive quadriceps NMES. The interventions will be administered five days per week for six weeks.\n\nClinical outcomes, including balance, functional mobility, gait performance, and disease severity, will be evaluated at baseline, post-treatment, and follow-up (week 14). In addition, ultrasound-based assessments of quadriceps muscle thickness and cross-sectional area will be performed to investigate muscle adaptations.\n\nThe results of this study are expected to provide comparative evidence regarding the effectiveness of these two rehabilitation approaches and contribute to optimizing rehabilitation strategies in Parkinson disease.",[27],[81,447,448,449,450,451,415,332],"Robot-assisted gait training","Neuromuscular electrical stimulation","Quadriceps muscle","Rehabilitation","Balance","2026-05-11",{"date":424,"type":32},{"date":455,"type":32},"2026-04-15",{"date":457,"type":21},"2027-06-15",{"name":459,"class":39},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":466,"targetDuration":468,"studyType":76,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":65},"100639559","a-multimodal-convergent-cohort-of-parkinsons-disease-at-fjmuuh-fjmuuh-pd-natural-history-study-100639559","NCT07588763","A Multimodal Convergent Cohort of Parkinson's Disease at FJMUUH (FJMUUH-PD): Natural History Study","Inclusion Criteria:\n\n* The diagnosis of Parkinson's disease (PD) will be made according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016) issued by the Parkinson's Disease and Movement Disorders Group of the Neurology Branch of the Chinese Medical Association, with confirmation by at least two neurologists. Eligible patients must meet all of the following criteria:\n\nDefinite diagnosis of parkinsonism; No absolute exclusion criteria for PD are present; At least 2 supportive criteria for PD are satisfied; No red flags suggestive of alternative diagnoses are present.\n\nExclusion Criteria:\n\n* Patients meeting any of the following conditions will be excluded from the study:\n\nInability to complete assessments using the Unified Parkinson Disease Rating Scale (UPDRS); Inability to complete assessments using the Mini-Mental State Examination (MMSE); History of recurrent stroke causing stepwise deterioration of parkinsonian symptoms; Diagnosis of secondary parkinsonism or Parkinson-plus syndromes; History of recurrent head trauma or confirmed encephalitis; Presence of severe organ dysfunction; Presence of severe endocrine diseases; Presence of hematological disorders; Presence of autoimmune diseases; Current diagnosis of malignant tumors.",{"count":467,"type":21},3000,"10 Years","Parkinson's disease (PD) is a common neurodegenerative disorder in middle-aged and elderly individuals, with a global incidence of 2.0% among adults aged 65 and over. Its pathogenesis remains unclear, and effective preventive and therapeutic approaches are lacking. PD severely impairs patients' physical and mental health and quality of life, while also imposing a substantial burden on families and society. This study will enroll patients with idiopathic PD diagnosed in the Department of Neurology, Fujian Medical University Union Hospital, from 2026 to 2036 to establish a research cohort. Using a non-interventional design, participants will undergo long-term follow-up through regular clinical visits, scale-based assessments, imaging examinations, and biological specimen testing. Corresponding data will be collected to build a research platform, aiming to clarify the pattern of disease progression and identify early diagnostic biomarkers. All testing methods are safe and reliable and will not pose additional risks to patients.\n\nThis study will be conducted in strict compliance with ethical requirements. Prior to enrollment, patients will be fully informed of the study details and will voluntarily provide written informed consent. To mitigate the risk of privacy disclosure, measures including coded management, data encryption, and access restriction will be implemented throughout the study to protect participants' privacy, safeguard their legitimate rights and interests, avoid additional financial burdens, and ensure the study is conducted in a standardized manner.\n\nI hereby pledge to protect the personal privacy of all study participants and respect their autonomy. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Review Measures for Life Sciences and Medical Research Involving Human Subjects.",[27],"2026-05-09",{"date":424,"type":32},{"date":474,"type":21},"2026-04-28",{"date":476,"type":21},"2035-12-31",{"name":478,"class":39},"Fujian Medical University Union Hospital",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":513},"100609952","changes-in-movement-fitness-and-quality-of-life-in-people-with-parkinsons-disease-after-different-exercise-programs-100609952","NCT07221266","Changes in Movement, Fitness, and Quality of Life in People With Parkinson's Disease After Different Exercise Programs","Changes in Motor Function, Quality of Life, Cardiorespiratory Fitness, and Physiological Markers in People With Parkinson's Disease Following Different Exercise Interventions.","Inclusion Criteria:\n\n1. Diagnosis of Parkinson's Disease\n2. Independent ambulation\n3. Hoehn and Yahr stage of 1-3\n4. 50 years of age or older\n5. Must speak English or Spanish\n\nExclusion Criteria:\n\n1. History of stroke\n2. History of heart attack\n3. Non-ambulatory\n4. Hoehn and Yahr of stage 4 or 5\n5. Osteoporosis\n6. Unmanaged Parkinson's medication",{"count":20,"type":21},[24],"Parkinson's disease (PD) is a progressive neurological condition that can affect movement, balance, endurance, and overall quality of life. Exercise is widely recognized as one of the most effective non-pharmacological treatments to help people with PD maintain function and independence. However, not all exercise programs produce the same results, and more research is needed to understand which types of exercise offer the greatest physical and physiological benefits.\n\nThis study is designed to examine how different types of structured exercise programs influence motor function, cardiorespiratory fitness, and markers of overall health in individuals with Parkinson's disease. The goal is to better understand how exercise can be used to improve movement, daily activities, and general well-being, as well as how it affects the body at a physiological level.\n\nParticipants will be adults diagnosed with idiopathic Parkinson's disease who are medically stable and able to safely participate in exercise. Before beginning the study, participants will complete screening procedures to ensure safety and eligibility. Eligible participants will then be assigned to one of several supervised exercise interventions conducted over a defined period. Each exercise program is designed to improve movement and function but differs in structure or training emphasis (for example, aerobic, functional, or task-specific activity).\n\nExercise sessions will take place under the supervision of licensed physical therapist. Each session will include warm-up, exercise, and cool-down components. Intensity will be monitored using heart rate and perceived exertion to ensure safety and appropriate challenge. Participants will attend sessions multiple times per week for 8 weeks.\n\nResearchers will collect information about movement abilities, balance, walking, endurance, and daily function using standardized physical therapy assessments such as gait tests, balance measures, and questionnaires related to quality of life at baseline, after 8-weeks of intervention and once more after a 4-week follow-up. In addition, blood samples will be collected to analyze physiological responses to exercise at the same 3 testing intervals. These samples will allow investigators to measure biomarkers related to cardiovascular health, nitric oxide availability, oxidative stress, and inflammation. These biological indicators can help identify how exercise affects underlying health mechanisms that may contribute to improved function in people with Parkinson's disease.\n\nAll data will be collected by trained research personnel who are experienced in working with individuals with Parkinson's disease. Participants will be monitored for safety at each session, and any adverse events will be documented and reviewed by the principal investigator and the Institutional Review Board (IRB).\n\nBy comparing changes across the different exercise programs, this study aims to determine which interventions have the most meaningful impact on mobility, endurance, and quality of life, as well as which ones produce measurable physiological benefits. Results from this research may help guide physical therapists, rehabilitation professionals, and people with Parkinson's disease in choosing the most effective exercise approaches for maintaining function and promoting overall health.\n\nUltimately, this project seeks to contribute to the growing evidence that targeted, engaging, and appropriately dosed exercise can play a key role in improving the lives of people living with Parkinson's disease. The findings may also help inform future clinical practice guidelines, community exercise programs, and long-term wellness strategies for individuals with movement disorders.",[27],[382,491,492,493,494,495,416,496,497,498,499,500,501,502,503],"Exercise intervention","Physical Therapy","Guided Cycling","Non-contact boxing","Aerobic Exercise","Endothelial Function","Blood Biomarkers","Homocysteine","Vitamin B-12","Inflammation","Oxidative stress","Balance Training","Motor Function","2026-05-04",{"date":506,"type":32},"2026-05-08",{"date":508,"type":32},"2026-04-21",{"date":510,"type":21},"2027-06-30",{"name":512,"class":39},"University of Texas, El Paso",2,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":16,"minAge":208,"maxAge":209,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":65},"100624796","phase-1-a-trial-to-evaluate-safety-and-efficacy-of-a-product-named-vgn-r08b-in-parkinsons-disease-patients-with-gba1-mutations-100624796","NCT07414290","A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R08b in Parkinson's Disease Patients With GBA1 Mutations","A Phase I\u002FII Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R08b Intra-cerebroventricular Injection in Parkinson's Disease Patients With GBA1 Mutations","Inclusion Criteria:\n\n* Subjects must meet all the following inclusion criteria:\n\n  1. Male or female, aged 30 to 70 years (inclusive) at the time of signing the informed consent form.\n  2. Documented GBA1-mutant Parkinson's disease, confirmed by medical history: meeting the International Parkinson and Movement Disorder Society (MDS) diagnostic criteria for idiopathic Parkinson's disease, with the presence of at least one pathogenic GBA1 gene mutation (confirmed by investigator interpretation).\n  3. Glucocerebrosidase (GCase) enzyme activity below the normal range, as measured from past or screening dried blood spot tests.\n  4. Hoehn-Yahr stage of 3 to 4 in the \"OFF\" state, an MDS-UPDRS Part III (motor examination) score ≥33 points in the \"OFF\" state, and the ability to walk without relying on a walker or wheelchair.\n  5. Montreal Cognitive Assessment (MoCA) score meeting the following criteria: \\>13 (for ≤6 years of education), \\>15 (for 7-12 years of education), or \\>16 (for \\>12 years of education) .\n  6. On an optimized levodopa regimen at screening (defined as a regimen optimized with at least a combination of levodopa preparations plus a dopamine agonist or MAO-B inhibitor, with levodopa administered ≥3 times per day and at a total daily dose of ≥300 mg), yet still experiencing suboptimal symptom control or significant \"wearing-off\" (as evidenced by a diary documenting a daily \"OFF\" time of ≥2.5 hours for three consecutive days during screening).\n  7. Stable Parkinson's disease symptoms and stable optimized anti-Parkinson's medication regimen for ≥4 weeks prior to screening; patients with GD-PD receiving Gaucher disease (GD) therapy must have been on stable enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 3 months prior to screening.\n  8. Men and women of childbearing potential must agree to consistently and correctly use a highly effective method of contraception from the screening period until at least 1 year after dosing.\n  9. Men must agree not to donate sperm, and women must agree not to donate eggs, from the screening period until at least 1 year after dosing.\n  10. The patient and\u002For the patient's legal guardian demonstrates understanding of the trial information, purpose, and risks described in the informed consent form, and is able to authorize the use of the patient's health information by providing a signed and dated informed consent form.\n  11. The patient has a reliable study partner (e.g., family member, friend, caregiver) who is willing and able to assist with study visits when needed, and to help provide information regarding the patient's health status, and cognitive and physical abilities (including providing input for rating scales).\n\nExclusion Criteria:\n\n* Subject has any of the following diseases or disease history\n\n  1. Patients with atypical or secondary parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders; or symptoms confirmed by the investigator to be induced by drugs, chemicals, or toxins; or those with other serious neurological conditions deemed by the investigator to significantly compromise the safety and efficacy evaluation of the investigational drug.\n  2. Patients with active infections (including viral infections such as HBV, HCV, or syphilis) or a history of severe infections within 12 weeks prior to screening (e.g., pneumonia, sepsis, or central nervous system infections such as meningitis or encephalitis).\n  3. Patients with severe liver disease, severe immunodeficiency, or autoimmune diseases within 6 months prior to screening, or those requiring long-term immunosuppressive therapy.\n  4. Patients with poorly controlled diabetes or hypertension, judged by the investigator as unsuitable for dosing or likely to substantially impact the efficacy and safety analysis of the investigational drug.\n  5. Patients with a history of stroke or transient ischemic attack (TIA), unstable angina, myocardial infarction, chronic heart failure (NYHA Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to screening.\n  6. Patients with a history of epileptic seizures or unexplained coma, deemed unsuitable by the investigator for participation in the trial.\n  7. Patients with a history of severe allergic reactions, or hypersensitivity to any inactive ingredient of the investigational drug or to immunosuppressants required by the trial protocol.\n  8. Patients with contraindications to corticosteroids or sirolimus, including but not limited to osteoporosis with vertebral fractures within 1 year prior to screening, poorly controlled hyperlipidemia or hypercholesterolemia, renal insufficiency, or interstitial lung disease.\n  9. Patients with newly diagnosed or unstable psychiatric disorders within 1 year prior to screening that may interfere with trial procedures and evaluations, including confusion, severe depression (HAMD score \\>35), or suicidal\u002Fself-harm tendencies.\n  10. Patients with a history of malignancy within 3 years prior to screening, except for completely resected non-melanoma skin cancer, non-metastatic prostate cancer, or fully cured carcinoma in situ that has remained stable for at least 6 months.\n  11. Patients with any other contraindications deemed by the investigator to potentially affect trial-related procedures, including lumbar puncture or intracerebral injection, such as spinal disorders, bleeding diathesis, clinically significant coagulation dysfunction, thrombocytopenia, or elevated intracranial pressure.",{"count":522,"type":21},17,[213,106],"A Phase I\u002FII Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R08b Intra-cerebroventricular injection in Parkinson's Disease Patients with GBA1 Mutations",[27],{"date":527,"type":32},"2026-05-01",{"date":529,"type":21},"2026-05-25",{"date":531,"type":21},"2031-09-01",{"name":533,"class":120},"Shanghai Vitalgen BioPharma Co., Ltd.",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":238,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":542,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":544,"conditions":545,"keywords":548,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":560},"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.",{"count":543,"type":21},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).",[27,154,546,379,547],"Gut Microbiome","Prodromal Parkinsons Disease",[549,217,550,551],"gut brain","Prodromal Parkinson's disease","healthy control","2026-04-29",{"date":554,"type":32},"2026-05-05",{"date":279,"type":21},{"date":557,"type":21},"2028-12-31",{"name":559,"class":39},"Duke University",7,{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":16,"minAge":568,"maxAge":18,"enrollmentInfo":569,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":65},"100616190","exercise-management-in-parkinsons-disease-100616190","NCT07302386","Exercise Management in Parkinson's Disease","The Effects of Exercise Management in Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosed with Idiopathic Parkinson's Disease by a neurologist according to the UK Parkinson's Disease Association Brain Bank clinical diagnostic criteria\n* H\\&Y Stage I-III\n* Montreal Cognitive Assessment Scale MoCA≥21\n* Having the necessary technological devices to participate in telerehabilitation\n* Being able to walk 100 meters\n* Having at least a primary school diploma\n\nExclusion Criteria:\n\n* Presence of a neurological disorder other than Parkinson's disease\n* Presence of any cardiopulmonary or musculoskeletal problem that affects gait and balance\n* Receiving Deep Brain Stimulation (DBS) treatment or having undergone DBS surgery in the past\n* Presence of vision or hearing problems","45 Years",{"count":49,"type":21},[24],"The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method.\n\nThe main research questions examined in this study are as follows:\n\n* Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme?\n* Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?",[27],"2026-03-30",{"date":575,"type":32},"2026-03-31",{"date":577,"type":32},"2025-12-15",{"date":579,"type":21},"2026-12-02",{"name":94,"class":39},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":16,"minAge":72,"maxAge":18,"enrollmentInfo":588,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":513},"100630960","inhibitory-control-and-gait-adaptability-in-parkinsons-disease-100630960","NCT07494461","Inhibitory Control and Gait Adaptability in Parkinson's Disease","Relationship Between Inhibitory Control and Gait Adaptability During Obstacle Crossing in People With Parkinson's Disease","Inclusion Criteria:\n\n* A clinical diagnosis of idiopathic Parkinson's disease;\n* Stable use of prescribed antiparkinsonian medication for at least two weeks;\n* Modified Hoehn and Yahr stage I to III;\n* Age between 18 and 80 years;\n* Ability to ambulate independently for at least 30 meters without assistive devices;\n* A Mini-Mental State Examination (MMSE) score of ≥ 24;\n* Corrected vision and hearing sufficient to effectively receive external stimuli\n\nExclusion Criteria:\n\n* The presence of any neurological, musculoskeletal, or cardiovascular disorders that could affect participation in this study;\n* The presence of psychiatric disorders that could interfere with the ability to follow instructions or comply with study procedures;\n* A history of brain surgery, such as deep brain stimulation (DBS)",{"count":5,"type":21},"People with Parkinson's disease (PD) may have difficulty stopping or changing their movements, especially when walking around obstacles.\n\nThe goal of this observational study is to learn if a specific cognitive function, called inhibitory control (the ability to stop or control actions) is associated with gait adaptability in people with Parkinson's disease. Gait adaptability means the ability to adjust how a person walks in response to changes in the environment, such as stepping over obstacles.\n\nThe main questions the study aims to answer are:\n\n* If brain activation related to inhibitory control, measured by EEG, is associated with gait adaptability during obstacle crossing in people with Parkinson's disease?\n* If behavioral inhibitory control is associated with gait adaptability during obstacle crossing in people with Parkinson's disease?\n\nParticipants take part in one study visit. During this visit, participants complete simple thinking tests, have their brain activity recorded using EEG, and perform walking tasks that include stepping over obstacles.",[27],[592,593,594],"Electroencephalography","Executive function","Obstacle crossing","2026-03-20",{"date":597,"type":32},"2026-03-27",{"date":599,"type":21},"2026-04-01",{"date":601,"type":21},"2029-08-31",{"name":603,"class":39},"National Yang Ming Chiao Tung University",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":16,"minAge":72,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":65},"100628704","motor-and-cognitive-exercise-in-parkinsons-disease-100628704","NCT07465107","Motor and Cognitive Exercise in Parkinson's Disease.","Motor and Cognitive Exercise in Parkinson's Disease. A Feasibility Randomized Clinical Trial","Ex-Park","Inclusion Criteria:\n\n* Diagnosis of PD according to MDS-PD criteria\n* Aged ≥ 18 years\n* Informed consent\n* PD symptoms ≥ 4 years\n* Independent gait\n\nExclusion Criteria:\n\n* Diagnosis of PD Dementia according to the MDS-PD Dementia criteria",{"count":613,"type":21},48,[24],"The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone.\n\n48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks.\n\nThe study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results.\n\nThis study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.",[27],[161,618,415,451,619,620,621,622],"Exercise Therapy","Motor-cognitive training","Dual-task","Neurological Rehabilitation","Psychomotor Performance","2026-03-06",{"date":625,"type":32},"2026-03-11",{"date":627,"type":32},"2025-03-26",{"date":629,"type":21},"2027-02-14",{"name":631,"class":39},"Annemette Lokkegaard",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":238,"sex":16,"minAge":72,"maxAge":373,"enrollmentInfo":640,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":642,"conditions":643,"keywords":644,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":655},"100588408","validation-of--synuclein-modifications-in-parkinsons-disorder-evolution-100588408","NCT06941012","Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution","Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution (VaMPiRE)","VaMPiRE","Inclusion Criteria:\n\n* • For PD subjects\n\n  * PD diagnosis according to MDS-UPDRS criteria and Hoehn and Yahr scale between I-IV (MED ON) for PD subjects\n  * Willing to participate. Participation is always voluntary.\n  * Willing and able to provide written informed consent to participate in the study or having a legal representative responsible for signing; the participant (or the legal representative) must understand the purpose, methods, and all information regarding the study.\n  * For non-PD subjects\n  * Normal neurological examination findings.\n  * Medical record (recent and remote medical history) available and reviewable by clinicians during the entire study period.\n  * Willing and able to provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* • For PD and non-PD subjects\n\n  * Clinically significant and severe cognitive decline and\u002For intellectual disability which can lead to impairment not caused by Parkinson's disease or any other disease that could better explain the patient's symptoms; The exclusion criteria involve neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (e.g. cerebral palsy, epilepsy \\[seizure disorders\\], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury).\n  * Fever (Temperature 38.0 °C (tympanic)).\n  * Acute infection (such as Flu, COVID-19) which could debilitate the patient and affect the data.\n  * Individuals with concurrent infections requiring systemic antimicrobial and\u002For antiviral therapy at the pre-dose examinations (e.g. HepC, HIV, TB).\n  * Life-threatening co-existing disease with life expectancy, which could lead to premature dropout.\n  * Any other neurological or systemic conditions that could confound results.",{"count":641,"type":21},1200,"Parkinson's disease (PD) presents a complex challenge due to its progressive neurodegenerative nature, affecting various bodily systems. Despite decades of research, understanding its onset and progression remains unclear, complicating early diagnosis and treatment. Recent advances in PD pathophysiology suggest promising treatments to slow disease progression, yet reversing cellular degeneration remains elusive. With novel therapies emerging, the need for early detection tools is urgent. However, validated biomarkers for PD diagnosis are lacking, relying on subjective scales like Hoehn and Yahr or costly medical imaging techniques. The accumulation of misfolded α-Synuclein (α-Syn) proteins in PD pathology has sparked interest, but defining diagnostic roles requires further investigation. Recent findings of α-Syn in neuronal-derived extracellular vesicles (NDEVs) from PD patients suggest a potential for novel diagnostic methods. Our proposed project, VαMPiRE, aims to conduct a longitudinal study involving 600 PD and 600 non-PD participants using a cluster-adjusted case-control methodology, to explore α-Syn isoforms and related biomarkers in NDEVs for early PD detection.\n\nWe plan to develop and validate an innovative in-vitro diagnostic (IVD) test capable of detecting PD's earliest stages and estimating disease prognosis and progression. Utilizing AI models to generate data analysis algorithms and collaboration with leading analytical laboratories and IVD manufacturers, we aim to ensure the reliability and feasibility of the developed prototype. Through consortium efforts, we envision licensing the generated intellectual property to drive the commercialization of our results.\n\nTwo round of blood sample extractions will be performed within a 24-month gap to PD participants and a single baseline for non-PD controls. All participants will be regularly followed up during this 24-month period to monitor disease evolution and treatment, and non-PD controls developing the disease will be part of a third cohort (expected to be around 24 subjects according to 4% incidence) that will confirm the sensitivity of the test in asymptomatic subjects. The unique aspect of the project is that we anticipate being able to detect theses 4% of non-PD participants that will go on to develop the disease, therefore demonstrating the value of these biomarkers to identify PD early.\n\nThe prototype will be validated for its discriminative capacity, using the first baseline set of PD and non-PD samples, and for its ability to detect the PD-progression comparing baseline and 24-months data plus blood samples.\n\nImproved early screening could allow for 270,000 new cases of PD to be detected earlier, improve the disease management of 9.4 M people currently diagnosed of PD and avoid losing a total of 5.8 million disability adjusted life years (DALYs) by 2028 leading also the development of better treatments.",[27],[645],"α-Synuclein","2026-02-27",{"date":648,"type":32},"2026-03-02",{"date":650,"type":32},"2025-05-12",{"date":652,"type":21},"2029-04-30",{"name":654,"class":39},"Casa di Cura IGEA",4,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":238,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":664,"conditions":665,"keywords":667,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":513},"100614607","clinical-validity-of-the-danu-sports-system-for-gait-and-balance-assessment-in-parkinsons-disease-100614607","NCT07281794","Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease","Parkinson's Group Inclusion Criteria:- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria.\n\n* PD stages I-III (Hoehn and Yahr Rating Scale)\n* Able to attend Northumbria University, Newcastle Upon Tyne for study visits.\n* Able to walk and stand unassisted for a minimum of 2-minutes.\n* Aged 50 years old or over\n\nParkinson's Group Exclusion Criteria:\n\n* History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)\n* Unable to walk or stand unaided.\n* Montreal Cognitive Assessment (MoCA) score \\\u003C 21\n* Significant issues unrelated to PD that may affect gait (e.g., musculoskeletal issues, back pain, recent surgery etc.)\n\nHealthy Control Inclusion Criteria:\n\n* Ability to attend Northumbria University, Newcastle Upon Tyne for study visits.\n* Aged 50 years old or over.\n* Able to walk and stand unassisted for a minimum of 2-minutes.\n\nHealthy Control Exclusion Criteria:\n\n* History of neurological disorders (e.g. Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)\n* Significant issues that may affect walking (e.g., musculoskeletal issues, back pain, recent surgery etc.)",{"count":663,"type":21},60,"This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.",[27,666],"Healthy (Controls)",[668,669,670],"DANU","Clinical Validation","Wearable Electronic Devices","2026-02-11",{"date":673,"type":32},"2026-02-12",{"date":675,"type":32},"2025-08-08",{"date":677,"type":21},"2027-09",{"name":679,"class":39},"Northumbria University"]