[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07442747":3,"trial-entities:NCT07442747":108,"trial-summary:NCT07442747":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":38,"interventions":41,"primary_outcomes":48,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":78,"locations":81,"central_contacts":102,"overall_officials":104,"references":106,"see_also_links":107},"NCT07442747","26-047","Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS","Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease","RECRUITING","2029-12-31","2026-07","2026-07-28","2026-07-08","The Cleveland Clinic","OTHER",true,"This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.","This study is investigating how aerobic exercise, specifically forced exercise (FE) and voluntary exercise (VE), affects movement, thinking, and brain activity in people with advanced Parkinson's disease who have deep brain stimulation (DBS). Over eight weeks, 36 participants will complete either a forced cycling program (where a motor helps them pedal faster than they could on their own) or a voluntary cycling program at a self-driven pace. Participants will complete an 8-week delayed start period to serve as a comparison before starting an exercise program.\n\nThe study will measure motor symptoms, cognitive performance, and brain activity from both the cortex (via EEG) and the subthalamic nucleus (via DBS device recordings) at several time points, including before treatment, after the 8-week exercise period, and again four weeks later. By analyzing how neural signals change at rest and during tasks, the study will evaluate the neural mechanisms that make exercise beneficial. This research could ultimately guide more effective, personalized exercise therapies to support people with advanced Parkinson's disease with DBS.",[19,20],"Parkinson's Disease","Deep Brain Stimulation",[22,20,23,24,25,26,27,28,29,30,31,32,33],"Parkinson","Parkinson's disease","Deep Brain Stimulation Surgery","DBS","Exercise","exercise training","Parkinson disease","Parkinson's","Parkinson's Disease with Deep Brain Stimulation","Percept","Cycling","Aerobic","INTERVENTIONAL","TREATMENT",[37],"PHASE2",{"count":39,"type":40},36,"ESTIMATED",[42],{"type":43,"name":26,"description":44,"armGroupLabels":45},"BEHAVIORAL","Participants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.",[46,47],"Forced Exercise (FE)","Voluntary Exercise (VE)",[49,53,56],{"measure":50,"description":51,"timeFrame":52},"Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)","Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function.\n\nChange in MDS-UPDRS III score from baseline to end-of-treatment (EOT) and baseline to EOT+4 weeks.","Baseline to EOT and Baseline to EOT+4 weeks",{"measure":54,"description":55,"timeFrame":52},"Relative Root Mean Square Error of a Grip Force Tracking Task","Participants are required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Relative root mean squared error quantifies deviation from the target force trajectory. Values are normalized for maximum target amplitude, with lower values indicating decreased error.",{"measure":57,"description":58,"timeFrame":52},"Local Field Potential Subthalamic Nucleus Beta at Rest","Normalized beta band activity is reported as the change in resting-state STN beta band (13-30Hz) power. Higher beta band suggests increased pathological electrical synchrony.",[],"ALL","18 Years",null,false,{"inclusion":65,"exclusion":71,"raw_text":77},[66,67,68,69,70],"Clinical diagnosis of Parkinson's disease","Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD","Clinically optimized DBS parameters for one month prior to enrollment","Ability to ambulate with or without an assistive device for 5 continuous minutes","Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments",[72,73,74,75,76],"Neurocognitive impairment that compromises the ability to provide informed consent","Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)","Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:","A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise","Current cardiac arrhythmia","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease\n* Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD\n* Clinically optimized DBS parameters for one month prior to enrollment\n* Ability to ambulate with or without an assistive device for 5 continuous minutes\n* Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments\n\nExclusion Criteria:\n\n* Neurocognitive impairment that compromises the ability to provide informed consent\n* Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)\n* Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:\n\n  1. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation.\n  2. Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible.\n* A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise\n* Current cardiac arrhythmia",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":99},"Cleveland Clinic","Cleveland","Ohio","44195","United States",[89,94,97],{"name":90,"role":91,"phone":92,"email":93},"MacKenzie Dunlap","CONTACT","216-219-3949","dunlapm4@ccf.org",{"name":95,"role":96},"Jay L Alberts, PhD","PRINCIPAL_INVESTIGATOR",{"name":98,"role":96},"Anson Rosenfeldt, PT, DPT, MBA",{"lat":100,"lon":101},41.4995,-81.69541,[103],{"name":90,"role":91,"phone":92,"email":93},[105],{"name":95,"affiliation":13,"role":96},[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Parkinson Disease",[],{"nct_id":4,"found":15,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an interventional study with 36 planned participants. It involves an eight-week control period followed by an eight-week cycling program.","completed","Aerobic Exercise and DBS for Parkinson's Disease","This study is for people with Parkinson's disease (PD) who have already received deep brain stimulation (DBS). It aims to understand how aerobic exercise, specifically cycling, affects movement, thinking, and brain activity in individuals with PD and DBS. You would participate in an eight-week cycling program, either with assistance (forced exercise) or at your own pace (voluntary exercise), after an initial eight-week control period. Researchers will measure your motor symptoms, cognitive performance, and brain activity to see how exercise helps. The study is currently unclear about its recruitment status and plans to enroll 36 participants.","Your progress will be followed for four weeks after the exercise period ends.",95,"You would complete 3 in-person cycling sessions per week for eight weeks, totaling 24 sessions. You would also have measurements taken at the beginning, after the exercise period, and four weeks later.","Not stated in the trial record.",[26],"v2"]