--- title: Can forced cycling improve walking nct_id: NCT07442747 phase: PHASE2 status: RECRUITING sponsor: The Cleveland Clinic study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07442747" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07442747" last_fetched: "2026-07-28T14:00:44.648Z" source: "Parkinson's Pathways (curated)" --- # Can forced cycling improve walking **Goal (in five words):** Can forced cycling improve walking **Official Title:** Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease **Trial ID:** [NCT07442747](https://clinicaltrials.gov/study/NCT07442747) ## Key Facts - **Phase:** PHASE2 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** The Cleveland Clinic - **Target Enrollment:** 36 participants - **Start Date:** 2026-07-08 - **Completion Date:** 2029-12-31 - **Conditions:** Parkinson's Disease, Deep Brain Stimulation - **Interventions:** Exercise - **Intervention Types:** BEHAVIORAL ## Summary For Families Goal: Learn how aerobic exercise, comparing forced cycling (a motor helps you pedal faster than you could on your own) and voluntary cycling (you pedal at your own pace), affects movement, thinking, and brain activity in people with advanced Parkinson's disease who have deep brain stimulation. Approach: Over an eight-week program with an initial delayed-start comparison, 36 participants will follow either the forced or voluntary cycling plan while researchers measure motor symptoms, cognitive tests, and brain signals using sensors on the head and recordings from the implanted deep brain stimulation device before exercise, after eight weeks, and again four weeks later. Eligibility: Adults 18 and older with Parkinson's who already have a bilateral Medtronic Percept deep brain stimulation implant with stable settings, who can walk for five continuous minutes, and who are willing to temporarily stop Parkinson's medications and turn off stimulation during some assessments; people with major memory problems, other brain diseases, certain heart rhythm problems, or musculoskeletal issues that prevent exercise are not eligible, and anyone needing medical clearance must obtain it before joining. ## What This Actually Involves **Placebo** _(From the protocol)_: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. **Visits** _(From the protocol)_: Supervised sessions occur three times per week, each session about 40 minutes, during an eight-week cycling program. > "This will be followed by an eight-week cycling program using a stationary bike equipped with a motor that assists pedaling. The motor helps maintain a cadence higher than the participant's voluntary pace, typically around 80-90 revolutions per minute, while the participant continues to actively pedal. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional." **Procedures** _(From the protocol)_: - Brain surgery / implanted device (Invasive) > "This study is focused on people with Parkinson's disease who already have deep brain stimulation devices." - Brain wave recording (EEG) (Non-invasive) > "The 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…" **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation. 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. * A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise * Current cardiac arrhythmia ``` ## Locations (1) - Cleveland Clinic, Cleveland, Ohio, United States _(41.4995, -81.6954)_ - MacKenzie Dunlap, (CONTACT), 216-219-3949, dunlapm4@ccf.org - Jay L Alberts, PhD, (PRINCIPAL_INVESTIGATOR) - Anson Rosenfeldt, PT, DPT, MBA, (PRINCIPAL_INVESTIGATOR) ## Central Contacts - MacKenzie Dunlap, (CONTACT), 216-219-3949, dunlapm4@ccf.org ## Making Contact: How to Call This Study Site ### Who to ask for Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study. ### What to say It is fine to read this out loud, word for word: > Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07442747. It is the one about "Can forced cycling improve walking". Could I speak with the study coordinator about taking part? If you are calling for a family member, use their name and mention that you help with their care. ### What they will ask you - The year of diagnosis - Current medications and their doses - Other health conditions - Any procedures already done, such as deep brain stimulation (DBS) - How far you are able to travel for study visits - Whether a care partner can come to visits with you ### What to have ready - A written list of current medications and doses - Your neurologist's name and phone number - The diagnosis date. The year is enough. - A recent visit summary from the neurologist, if you have one ### What to ask them - How many visits are there, and how long does each visit take? The listing already answers this: Supervised sessions occur three times per week, each session about 40 minutes, during an eight-week cycling program. Ask the coordinator to confirm it still applies. - Is travel, parking, or my time reimbursed? - Is there a placebo group, and what is my chance of being in it? The listing already answers this: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. Ask the coordinator to confirm it still applies. - Would I need to stop or pause any of my current medications? - What happens when the study ends? Could I stay on the treatment if it helps? ### What to expect - Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal. - Many callers do not end up joining. Screening out is common and is not a judgment about you or your health. - Asking questions commits you to nothing. You can stop the process at any point. --- *Canonical: https://parkinsonspathways.com/trial/NCT07442747* *HTML version: https://parkinsonspathways.com/trial/NCT07442747* *Source data: https://clinicaltrials.gov/study/NCT07442747*