Status:
RECRUITING
Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
United States Department of Defense
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will ...
Detailed Description
Parkinson's disease (PD) is a progressive neurological disease, most prevalent in older adults, estimated to affect over 12 million people world-wide by 2040. Traditionally considered a motor disorder...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05972759
Start Date
August 15 2023
End Date
December 31 2025
Last Update
July 24 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195