[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"basal-ganglia-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:basal-ganglia-diseases":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,108,147,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100607383","study-of-axial-and-cognitive-symptoms-and-biomarkers-of-neurodegeneration-in-brain-first-and-body-first-pd-100607383",false,"NCT07187843","Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD","Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes","BRABOAXPD","Inclusion Criteria:\n\n* Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \\[123I-MIBG\\].\n* Free and informed consent expressed by the participant.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Inability to express free and informed consent.\n* Patient with a doubtful diagnosis.\n* Participant under 18 years of age.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed \"Brain-First\" and \"Body-First\" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.\n\nFindings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.",[25,26,27,28,29],"Parkinson Disease","Parkinsonian Disorders","Brain Disease","Basal Ganglia Diseases","Synucleinopathies",[31,32,33,34,35,36,37,38],"Neurodegenerative Diseases","Nervous System Diseases","Movement Disorders","biomarker","neuroinflammation","brain-first","body-first","axial symptoms","RECRUITING","2026-04-22",{"date":42,"type":43},"2026-04-23","ACTUAL",{"date":45,"type":43},"2024-09-04",{"date":47,"type":21},"2031-05",{"name":49,"class":50},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":51},"100617877","slowing-cognitive-decline-in-alpha-synucleinopathies-by-enhancing-physical-activity-100617877","NCT07324330","Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity","ALPHA-FIT","Inclusion Criteria:\n\niRBD:\n\n* Age: 50-80 years\n* Polysomnographically confirmed diagnosis of iRBD\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nHealthy controls:\n\n* Age: 50-80 years\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nExclusion Criteria:\n\niRBD:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n\nHealthy controls:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n* clinically diagnosed iRBD",true,"50 Years","80 Years",{"count":63,"type":21},130,"INTERVENTIONAL",[66],"NA","α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.\n\nThe aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.\n\nEighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the \"Deutsches Zentrum für Neurodegenerative Erkrankungen\" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.",[25,69,31,28,70,29,32,71,72,26],"Prodromal Stage","Central Nervous System Diseases","Cerebral Disorder","Brain Diseases",[74,75,76,77,78,79,34,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"intervention","movement","iRBD","prodromal parkinson's","non-pharmacologic","alpha-synucleinopathy","cognitive decline","executive function","MRI","lifestyle","prevention","RCT","motor decline","smartphone","smartwatch","accelerometer","scalable","prodromal","PD","Parkinson","Lewy-body","MSA","multiple system atrophy","dementia","2026-01-14",{"date":100,"type":43},"2026-01-16",{"date":102,"type":43},"2025-12-04",{"date":104,"type":21},"2029-12-01",{"name":106,"class":107},"University Hospital, Bonn","OTHER",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":64,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100592416","slow-speed-slowing-parkinsons-early-through-exercise-dosage-100592416","NCT06993142","Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage","Slow-SPEED","Inclusion criteria\n\n1. previously identified LRRK2 G2019S or GBA N370S variant based on genotyping\n2. aged 50 years or older\n3. able to understand the English language\n4. being able to walk independently inside the home without the use of a walking aid\n5. in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer)\n6. Not in a high physical activity range during the 4-week eligibility and baseline period\n\nExclusion criteria\n\n1. clinically diagnosed or self-reported diagnosis neurodegenerative disease\n2. self-reported falls of three or more per year\n3. dexterity problems or cognitive impairments hampering smartphone use\n4. if they are not aware of and do not wish to be informed about an increased risk of developing diseases associated with the LRRK2 or GBA1 risk variant\n5. if individual is not community-dwelling\n6. in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)",{"count":116,"type":21},600,[66],"The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation.\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, the investigators aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[25,69,31,28,70,29,32,71,72,26,120],"Genetic Predisposition",[122,123,124,125,126,127,128,129,130,25,131,132,133,134,135],"Physical activity","Prevention","Remote","Mobile Health (mHealth)","Feasibility","Exercise","Digital biomarker","Motivational application","Walking","Prodromal","LRRK2","GBA1","Genetic","Smartwatch","NOT_YET_RECRUITING","2025-05-28",{"date":139,"type":43},"2025-06-03",{"date":141,"type":21},"2025-07-01",{"date":143,"type":21},"2029-06-30",{"name":145,"class":107},"Radboud University Medical Center",2,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":64,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":51},"100530935","slow-speed-nl-slowing-parkinsons-early-through-exercise-dosage-netherlands-100530935","NCT06193252","Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands","Slow-SPEED-NL","Inclusion Criteria:\n\n* previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)\n* able to understand the Dutch language\n* being able to walk independently inside the home without the use of a walking aid\n* Not in a high physical activity range during the 4-week eligibility and baseline period\n* in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.\n\nExclusion Criteria:\n\n* clinically diagnosed or self-reported diagnosis neurodegenerative disease;\n* self-reported weekly falls in the previous 3 months;\n* dexterity problems or cognitive impairments hampering smartphone use;\n* if they do not wish to be informed about an increased risk of developing diseases associated with iRBD\n* if individual is not community-dwelling\n\nExclusion criteria for MRI only:\n\n* history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery\n* claustrophobia\n* implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)\n* metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters\n* pregnancy\n* fear for incidental finding",{"count":155,"type":21},110,[66],"The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months).\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[25,69,31,26,159,28,70,29,32,71,72],"REM Sleep Behavior Disorder",[161,123,124,125,126,127,128,162,163,82,129,130,25,131],"Physical Activity","Blood","Imaging",{"date":139,"type":43},{"date":166,"type":43},"2024-01-15",{"date":168,"type":21},"2027-12-01",{"name":145,"class":107},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":179,"conditions":180,"keywords":193,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100557135","digital-diagnostics-and-intervention-services-for-parkinsons-disease-100557135","NCT06534177","Digital Diagnostics and Intervention Services for Parkinson's Disease","Development of Digital Diagnostics and Intervention Services for Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \\[stroke, multiple sclerosis, arthritis or osteoporosis\\]\n* Able to self-report history of daily gait freezing and\u002For festination for people with PD or gait and\u002For transfers affected by condition\n* Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands Healthy participants \\[Phase 1,2,3\\]\n* With no long-term conditions affecting movement\n* Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and\n* if over 69 used to carrying out this level of exercise\n* Adult (+18 years old)\n* Normal or corrected-to-normal vision (Snellen Visual Acuity \\> 12\u002F18) or safe to mobilise with support\n* Montreal Cognitive assessment score \\>21 or ability to follow 2 stage commands\n\nExclusion Criteria:\n\n* Participants with long-term conditions affecting movement\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system Healthy participants\n* Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand\n* testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.\n* Cognitive impairment affecting ability to safely participate and follow instructions\n* Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)\n* Any skin conditions or broken skin in the calf and behind knee area\n* Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system",{"count":178,"type":21},80,"People with Parkinson's have infrequent clinical consultation (once every 12-18 months) and limited rehabilitation.\n\nAssessment play an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes. There is a strong need for more frequent and accurate Parkinson's assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly. There is a need to develop good home digital physiotherapy tools to increase the amount of therapy. Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home. The investigators aim to conduct a clinical study with 50 people with Parkinson's (50 from UK) with the UPDRS, (a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinson's disease) and 30 healthy adults. The investigators will develop and investigate if two new digital devices, one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS (motor) using digital gait and ophthalmic features in the clinic setting. The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home. The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community",[72,70,32,181,182,25,28,33,29,183,184,185,186,187,188,189,190,191,192],"Joint Diseases","Musculoskeletal Diseases","Neuro-Degenerative Disease","Demyelinating Disease, Autoimmune, CNS","Demyelinating Disease","Autoimmune Diseases","Immune System Diseases","Bone Diseases, Metabolic","Bone Diseases","Arthritis","Osteoporosis","Multiple Sclerosis",[194,195,196,197,198],"parkinson's disease","osteoarthritis","stroke","MS","osteoporosis","2024-08-06",{"date":201,"type":43},"2024-08-09",{"date":203,"type":21},"2024-10-15",{"date":205,"type":21},"2026-03-01",{"name":207,"class":107},"University of Exeter"]