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
NCT Number: NCT07442747
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Anson Rosenfeldt, PT, DPT, MBA
PRINCIPAL_INVESTIGATOR
Jay L Alberts, PhD
PRINCIPAL_INVESTIGATOR
MacKenzie Dunlap
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
The Cleveland Clinic
Other
Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease
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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