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Completed

NCT Number: NCT05972759

Identifying the Neural Signature of Exercise to Advance Treatment of PD Cognitive Declines

Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Parkinson's disease (PD) is a progressive neurological disease, most prevalent in older adults, estimated to affect over 12 million people world-wide by 2040. Traditionally considered a motor disorder, the impact of PD on cognitive performance is now widely accepted with 80% of PD patients developing executive function impairments. Typical PD related cognitive effects include impaired information processing, set-switching, working memory and dual-tasking. While antiparkinsonian medication and deep brain simulation (DBS) are effective in managing disease symptoms, disease modification has remained elusive. Exercise has been proposed as the Universal Prescription for PD capable of slowing disease progression; stationary cycling in particular has been suggested as an ideal exercise modality for people with PD (PwPD). The investigator's seminal tandem cycling study was the first to utilize forced exercise (FE) in human PD patients and demonstrated a 30% improvement in clinical ratings compared to voluntary exercise (VE). Briefly, FE is a mode of high intensity exercise originating in animal models of PD in which voluntary exercise rate is augmented, but not replaced. Thus, PwPD were assisted in pedaling at a higher rate (cadence) on the tandem cycle compared to those on a standard stationary cycle performing voluntary exercise (VE). This work resulted in a paradigm shift in terms of recommending high intensity exercise for PwPD. Despite the potential of exercise to alter disease progression, its mechanism of action and effects on basal ganglia function are not understood.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Forced and Voluntary Exercise

Other

Twenty-five participants with PD utilizing the Medtronic Percept PC DBS system will be enrolled for this project and complete a single bout of both FE and VE. The 150-minute experimental session will be completed in the OFF antiparkinsonian and Off-DBS state.

Primary outcomes

  1. Local Field Potentials during Cognitive Testing

    Time frame: an average of 3 total days

    Change in power in frequency bands of interest

  2. Trail Making Test A & B

    Time frame: an average of 3 total days

    Change in neuropsychological tests designed to evaluate set-switching and attention

  3. Information Processing

    Time frame: an average of 3 total days

    Change in mobile application of simple and choice reaction time

  4. N-Back Test

    Time frame: an average of 3 total days

    Change in working memory test of word recall

  5. Force-tracking with n-back

    Time frame: an average of 3 total days

    Change in upper extremity motor control assessment with cognitive component

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Feb 27, 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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