Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS

NCT07442747 | Not Yet Recruiting DMC

• 2 other identifiers: 26-047R01AG092298
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.

Conditions

Parkinson's Disease; Deep Brain Stimulation

Keywords

Parkinson; Deep Brain Stimulation; Parkinson's disease; Deep Brain Stimulation Surgery; DBS; Exercise; exercise training; Parkinson disease; Parkinson's; Parkinson's Disease with Deep Brain Stimulation; Percept; Cycling; Aerobic

Outcome Measures

Primary Outcomes (3)

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)

  Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. Change in MDS-UPDRS III score from baseline to end-of-treatment (EOT) and baseline to EOT+4 weeks.

  Baseline to EOT and Baseline to EOT+4 weeks

• Relative Root Mean Square Error of a Grip Force Tracking Task

  Participants are required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Relative root mean squared error quantifies deviation from the target force trajectory. Values are normalized for maximum target amplitude, with lower values indicating decreased error.

  Baseline to EOT and Baseline to EOT+4 weeks

• Local Field Potential Subthalamic Nucleus Beta at Rest

  Normalized beta band activity is reported as the change in resting-state STN beta band (13-30Hz) power. Higher beta band suggests increased pathological electrical synchrony.

  Baseline to EOT and Baseline to EOT+4 weeks

Study Arms (2)

Forced Exercise (FE)

EXPERIMENTAL

Participants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program using a stationary bike equipped with a motor that assists pedaling. The motor helps maintain a cadence higher than the participant's voluntary pace, typically around 80-90 revolutions per minute, while the participant continues to actively pedal. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored to ensure safety and maintain aerobic intensity. The goal is to provide consistent, high-rate cycling that participants likely could not achieve on their own.

Behavioral: Exercise

Voluntary Exercise (VE)

EXPERIMENTAL

Participants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored for safety and consistency.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Participants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.

Forced Exercise (FE); Voluntary Exercise (VE)

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of Parkinson's disease
• Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD
• Clinically optimized DBS parameters for one month prior to enrollment
• Ability to ambulate with or without an assistive device for 5 continuous minutes
• Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments

You may not qualify if:

• Neurocognitive impairment that compromises the ability to provide informed consent
• Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
• Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:
• If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation.
• Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible.
• A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise
• Current cardiac arrhythmia

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jay L Alberts, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MacKenzie Dunlap

CONTACT

216-219-3949; dunlapm4@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share