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Recruiting NCT07442747

Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS

Phase II Interventional Parkinson's Disease Deep Brain Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Parkinson's Disease, Deep Brain Stimulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Exercise
    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 outcome measures

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) [Time frame: Baseline to EOT and Baseline to EOT+4 weeks]
  • Relative Root Mean Square Error of a Grip Force Tracking Task [Time frame: Baseline to EOT and Baseline to EOT+4 weeks]
  • Local Field Potential Subthalamic Nucleus Beta at Rest [Time frame: Baseline to EOT and Baseline to EOT+4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT07442747 · 26-047 · R01AG092298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗