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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collection days two and three
Awards & highlights
Study Summary
This trial tests how 15 PwPDs react to exercise while off meds when undergoing DBS surgery. Motor response is tested using MDS-UPDRS and force-tracking tasks.
Who is the study for?
This trial is for adults with Parkinson's Disease (PD) who have had Deep Brain Stimulation (DBS) surgery using the Medtronic Percept system at least six months ago. Participants must be able to use a stationary cycle and agree to stop PD medications and DBS stimulation during the study. They need exercise clearance, but can't join if they have dementia, other neurological diseases, musculoskeletal issues affecting cycling ability, or uncontrolled cardiovascular conditions.Check my eligibility
What is being tested?
The study examines how forced and voluntary exercise on a stationary bike affects neural activity in the Subthalamic Nucleus of people with PD who've undergone DBS surgery. It measures brain activity before, during, and after exercise sessions while participants are off their PD medication.See study design
What are the potential side effects?
Since this trial involves physical exercise rather than medication or invasive procedures, side effects may include typical exercise-related responses such as fatigue or muscle soreness. However, specific risks related to Parkinson's symptoms without medication will be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ data collection days two and three
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collection days two and three
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Finger Tapping
Force Tracking
Local Field Potential
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Two modes of high intensity exercise
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Who is running the clinical trial?
Jay AlbertsLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurological condition, not Parkinson's, affecting my movement or thinking.My deep brain stimulation settings have been stable for 3 months.I do not have uncontrolled heart issues or untreated blood clots.I am willing to stop my Parkinson's medication and deep brain stimulation.I can safely get on and off a stationary bike with a backrest.I have a physical condition that prevents me from cycling.I have received medical clearance to exercise based on the ACSM guidelines.I have been diagnosed with Parkinson's disease by a specialist.I have had Medtronic Precept DBS implants for my Parkinson's for over 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings still available for this clinical trial?
"This study, that was initially posted in July of 2023 and most recently edited on June 6th 2023 is no longer accepting patients. However, there are 528 other medical trials currently recruiting volunteers."
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