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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 an average of 3 total days
Awards & highlights
Study Summary
This trial will study 25 people with Parkinson's Disease using a medical device to measure effects of exercise on the condition.
Who is the study for?
This trial is for adults with Parkinson's Disease (PD) who have had a Medtronic Percept PC DBS system in place for at least six months and stable settings for three. Participants must be able to stop PD medications and DBS, pass an exercise safety screening or get doctor clearance, and safely use a recumbent cycle.Check my eligibility
What is being tested?
The study tests the effects of one session each of forced (FE) and voluntary exercise (VE) on cognitive function in PD patients without their usual medication or DBS stimulation. The exercises are done during a single 150-minute session.See study design
What are the potential side effects?
Potential side effects from participating may include typical risks associated with physical exercise such as muscle strain, fatigue, or cardiovascular stress especially since participants will not take their regular PD medication during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ an average of 3 total days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 3 total days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Force-tracking with n-back
Information Processing
Local Field Potentials during Cognitive Testing
+2 moreTrial 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?
The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,365,533 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,674 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My deep brain stimulation settings have been stable for 3 months.I have a condition that makes it hard for me to ride a bike.I have had Medtronic Precept DBS devices for Parkinson's for over 6 months.I can safely get on and off a stationary bike with a backrest.I have a neurological condition, not Parkinson's, affecting my movement or thinking.I am willing to stop my Parkinson's medication and deep brain stimulation.I have been medically cleared to exercise based on the ACSM guidelines.I have been diagnosed with Parkinson's disease by a specialist.I do not have uncontrolled heart issues or untreated blood clots.
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 presently any openings for participants in this experiment?
"According to clinicaltrials.gov, this research is no longer in need of participants after being added on August 15th 2023 and last edited a month later. In spite of this, there are still 1,095 other trials that require volunteers at the present time."
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