Identifying how exercise affects cognitive decline in Parkinson's disease
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
NA · The Cleveland Clinic · NCT05972759
This study is testing how different types of exercise can affect thinking skills in people with Parkinson's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT05972759 on ClinicalTrials.gov |
What this trial studies
This study involves twenty-five participants with Parkinson's disease who will undergo a single session of forced exercise (FE) and voluntary exercise (VE) while using the Medtronic Percept PC deep brain stimulation (DBS) system. The session will last 150 minutes and will take place when participants are off their antiparkinsonian medication and DBS stimulation. The goal is to explore the neural signatures associated with different exercise modalities to better understand their impact on cognitive performance in Parkinson's disease. This research aims to provide insights into how high-intensity exercise can potentially modify disease progression and improve cognitive function.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Parkinson's disease who have been treated with bilateral Medtronic Precept DBS for at least six months.
Not a fit: Patients with dementia or significant neurocognitive impairments that affect their ability to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes for patients with Parkinson's disease through tailored exercise interventions.
How similar studies have performed: Previous studies have shown promising results with high-intensity exercise in Parkinson's disease, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult with a diagnosis of PD by a movement disorders neurologist * Previous placement, at least six months, of bilateral Medtronic Precept DBS as standard of care treatment for their PD. * Stable and clinically optimized DBS parameters for three months prior to enrollment. * Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with an upright back. * Willingness to withhold antiparkinsonian medication and DBS stimulation. * 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: * Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent. * A musculoskeletal issue that limits one's ability to cycle * Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) that impacts motor or cognitive function * Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia, uncontrolled hypertension, untreated deep vein thrombosis, etc.
Where this trial is running
Cleveland, Ohio and 1 other locations
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: MacKenzie Dunlap, BS
- Email: dunlapm4@ccf.org
- Phone: 216-219-3949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Deep Brain Stimulation, DBS