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

NCT05905302 | Completed Results

• 1 other identifier: 1R21NS129147-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (3)

• Finger Tapping

  Finger tapping portion of the the Movement Disorders Society-Unified Parkinson's Disease Rating Scale subscale III (MDS-UPDRS III). The MDS-UPDRS III assesses motor function in Parkinson's disease using eighteen items scored on a 0-4 scale resulting in a score ranging from 0-72. A higher score (larger number) indicates more motor symptoms. For this outcome, item number 4 (finger tapping rated 0-4) for the participant's dominant hand in the MDS-UPDRS III was analyzed.

  Pre- and Post-Exercise

• Force Tracking

  Participants were required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Time within range is the percentage of the trial that participants were within 5% of the target force, with higher values indicating improved accuracy.

  Pre- and Post-Exercise

• Local Field Potential

  Normalized beta band activity (the change in beta power relative to a resting baseline) is reported as the mean across voluntary exercise (VE) and forced exercise (FE) sessions. The ON DBS condition was not tested for this outcome measure.

  Pre- and Post-Exercise

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Two modes of high intensity exercise

Other: Forced and Voluntary Exercise

Interventions

Forced and Voluntary Exercise OTHER

Participants will complete a forced exercise (FE) and voluntary exercise (VE) session. Forced exercise is a mode of high intensity exercise in which voluntary exercise rate is augmented, but not replaced. Voluntary exercise is standard stationary cycling. FE and VE exercise sessions will be Off antiparkinsonian medication. The order in which exercise session is conducted first will be randomized. Bilateral neural activity of the STN will be continuously recorded for 130 minutes (pre, during FE or VE and post-exercise).

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jay Alberts: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Koop MM, Rosenfeldt AB, Berki V, Bazyk A, Davidson S, Malan NS, Nagel S, Walter BL, Liao JY, Alberts JL. A novel methodological approach to understanding the cortical and subcortical effects of aerobic exercise in Parkinson's disease. Front Hum Neurosci. 2025 Oct 20;19:1657049. doi: 10.3389/fnhum.2025.1657049. eCollection 2025.

  PMID: 41189627 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Jay Alberts, PhD
• Organization: Cleveland Clinic

albertj@ccf.org

216-445-3222

Study Officials

• Jay Alberts, PhD

  Staff

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff

Model Details: Fifteen Parkinson's disease patients 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.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 15, 2023
• Study Start: August 15, 2023
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)