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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972759
• Other study ID #: 22-568
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: MacKenzie Dunlap, BS
• Phone: 216-219-3949
• Email: dunlapm4[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Parkinson Disease

Intervention

Other:
• Forced and voluntary exercise
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Field Potentials during Cognitive Testing	Change in power in frequency bands of interest	an average of 3 total days
Primary	Trail Making Test A & B	Change in neuropsychological tests designed to evaluate set-switching and attention	an average of 3 total days
Primary	Information Processing	Change in mobile application of simple and choice reaction time	an average of 3 total days
Primary	N-Back Test	Change in working memory test of word recall	an average of 3 total days
Primary	Force-tracking with n-back	Change in upper extremity motor control assessment with cognitive component	an average of 3 total days