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NCT Number: NCT07442747

Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Anson Rosenfeldt, PT, DPT, MBA

PRINCIPAL_INVESTIGATOR

Jay L Alberts, PhD

PRINCIPAL_INVESTIGATOR

MacKenzie Dunlap

CONTACT

[email protected]

216-219-3949

About this study

This study is investigating how aerobic exercise, specifically forced exercise (FE) and voluntary exercise (VE), affects movement, thinking, and brain activity in people with advanced Parkinson's disease who have deep brain stimulation (DBS). Over eight weeks, 36 participants will complete either a forced cycling program (where a motor helps them pedal faster than they could on their own) or a voluntary cycling program at a self-driven pace. Participants will complete an 8-week delayed start period to serve as a comparison before starting an exercise program.

The study will measure motor symptoms, cognitive performance, and brain activity from both the cortex (via EEG) and the subthalamic nucleus (via DBS device recordings) at several time points, including before treatment, after the 8-week exercise period, and again four weeks later. By analyzing how neural signals change at rest and during tasks, the study will evaluate the neural mechanisms that make exercise beneficial. This research could ultimately guide more effective, personalized exercise therapies to support people with advanced Parkinson's disease with DBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline to EOT and Baseline to EOT+4 weeks

    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.

  2. Relative Root Mean Square Error of a Grip Force Tracking Task

    Time frame: Baseline to EOT and Baseline to EOT+4 weeks

    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.

  3. Local Field Potential Subthalamic Nucleus Beta at Rest

    Time frame: Baseline to EOT and Baseline to EOT+4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

MacKenzie Dunlap

CONTACT

[email protected]

216-219-3949

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 2, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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