Parkinson's DiseasePhase 2NCT07442747
Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS
A Phase 2 study testing Exercise in people with Parkinson's Disease and Deep Brain Stimulation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Deep Brain Stimulation
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Medical clearance for moderate-high intensity exercise given by treating physician or physician extender
Who cannot join
- Neurocognitive impairment that compromises the ability to provide informed consent
- Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
- A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise
- Current cardiac arrhythmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
MacKenzie Dunlap, 216-219-3949, dunlapm4@ccf.org
Jay L Alberts, PhD
About this study
Official title: Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease
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.
Read the detailed description
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.
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 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.
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Being tested
- Exercise
- Keywords
- Parkinson, Deep Brain Stimulation, 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
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Forced Exercise (FE) | Experimental | Participants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. 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. Heart rate will be monitored to ensure safety and maintain aerobic intensity. The goal is to provide consistent, high-rate cycling that participants likely could not achieve on their own. Receives: Behavioral: Exercise |
| Voluntary Exercise (VE) | Experimental | Participants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored for safety and consistency. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Change in MDS-UPDRS III score from baseline to end-of-treatment (EOT) and baseline to EOT+4 weeks.
Measured: Baseline to EOT and Baseline to EOT+4 weeks
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.
Measured: Baseline to EOT and Baseline to EOT+4 weeks
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.
Measured: Baseline to EOT and Baseline to EOT+4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start8 Jul 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jay Alberts, The Cleveland Clinic
- Investigators
- Jay L Alberts, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442747
- Sponsor's protocol ID
- 26-047
- Other IDs
- R01AG092298
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07442747
- Acronym / sponsor ID
- 26-047
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Keywords
- Parkinson, Deep Brain Stimulation, Parkinson's disease, Deep Brain Stimulation Surgery, DBS, Exercise, exercise training, Parkinson disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forced Exercise (FE) | Experimental | Behavioral: ExerciseParticipants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. 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. Heart rate will be monitored to ensure safety and maintain aerobic intensity. The goal is to provide consistent, high-rate cycling that participants likely could not achieve on their own. |
| Voluntary Exercise (VE) | Experimental | Behavioral: ExerciseParticipants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored for safety and consistency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Neurocognitive impairment that compromises the ability to provide informed consent
- Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
- A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise
- Current cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants 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. | Behavioural | Forced Exercise (FE), Voluntary Exercise (VE) |
Primary outcome
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)
Time frame: Baseline to EOT and Baseline to EOT+4 weeks
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. Change in MDS-UPDRS III score from baseline to end-of-treatment (EOT) and baseline to EOT+4 weeks.
Relative Root Mean Square Error of a Grip Force Tracking Task
Time frame: Baseline to EOT and Baseline to EOT+4 weeks
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.
Local Field Potential Subthalamic Nucleus Beta at Rest
Time frame: Baseline to EOT and Baseline to EOT+4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay L Alberts, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Parkinson's Disease and Deep Brain Stimulation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MacKenzie Dunlap (216-219-3949, dunlapm4@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) (time frame: Baseline to EOT and Baseline to EOT+4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.