Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Neurocognitive impairment that compromises the ability to provide informed consent
Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralParticipants 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Forced Exercise (FE)Experimental treatment 1 intervention
Group B: Voluntary Exercise (VE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)
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 weeks2
Relative Root Mean Square Error of a Grip Force Tracking Task
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 weeks3
Local Field Potential Subthalamic Nucleus Beta at Rest
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.
Time frame
Baseline to EOT and Baseline to EOT+4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov