Examining how exercise affects brain activity in Parkinson's disease

The Impact of Exercise on Subthalamic Nucleus Neural Activity in Parkinson's Disease

This study tests how different types of exercise affect brain activity in people with Parkinson's disease who have had deep brain stimulation to see if it can help improve their movement and slow down the disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05905302 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of forced and voluntary exercise on neural activity in the subthalamic nucleus of individuals with Parkinson's disease who have undergone deep brain stimulation. Participants will engage in exercise sessions on a stationary cycle while off their antiparkinsonian medication, allowing researchers to record neural activity continuously for 130 minutes. The study aims to understand the mechanisms by which exercise may influence disease progression and motor function in Parkinson's patients. The outcomes will be assessed using standardized motor exams and force-tracking tasks.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Parkinson's disease who have had bilateral deep brain stimulation for at least six months and are able to safely participate in exercise.

Not a fit: Patients with dementia or significant neurocognitive impairments, as well as those with musculoskeletal issues that prevent safe exercise, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how exercise can be used to improve motor function and potentially slow the progression of Parkinson's disease.

How similar studies have performed: Previous studies have shown promising results with high-intensity exercise in Parkinson's patients, indicating potential for this approach to be effective.

Eligibility criteria

Inclusion Criteria:

1. Adult with a diagnosis of PD by a movement disorders neurologist
2. Previous placement, at least six months, of bilateral Medtronic Precept DBS as standard of care treatment for their PD.
3. Stable and clinically optimized DBS parameters for three months prior to enrollment.
4. Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with an upright back.
5. Willingness to withhold antiparkinsonian medication and DBS stimulation.
6. Exercise clearance using the American College of Sports Medicine (ACSM) Pre-participation Health Screen: a. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation; b. Those who choose not to obtain physician clearance will not be eligible for participation.

Exclusion Criteria:

1. Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent.
2. A musculoskeletal issue that limits one's ability to cycle
3. Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) that impacts motor or cognitive function
4. Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia, uncontrolled hypertension, untreated deep vein thrombosis, etc.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: MacKenzie Dunlap, BS

Conditions Parkinson Disease; Deep Brain Stimulation