CompletedNot Applicable

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

United States15 participantsStarted 2023-08-15

Plain-language summary

Fifteen PwPD who have undergone DBS surgery and utilize the Percept system will complete a FE and VE exercise session on a stationary cycle while Off antiparkinsonian medication. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre-, during FE or VE and post-exercise). The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III Motor Exam and upper extremity force-tracking task will be used to determine motor response to exercise.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Finger Tapping

Timeframe: Pre- and Post-Exercise

Force Tracking

Timeframe: Pre- and Post-Exercise

Local Field Potential

Timeframe: Pre- and Post-Exercise

Trial details

NCT IDNCT05905302

SponsorJay Alberts

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-20

Results submitted2025-09-29

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.