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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
No Placebo-Only Group
Summary
This trial involves people with Parkinson's Disease doing two types of stationary bike exercises. One type is where they pedal at their own pace, and the other is where they are helped to pedal faster. The goal is to see if higher intensity exercise can improve their symptoms more effectively.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Force-tracking with n-back
Information Processing
Local Field Potentials during Cognitive Testing
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Two modes of high intensity exercise.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Parkinson's Disease (PD) primarily aim to manage motor symptoms by addressing the dopamine deficiency in the brain. Levodopa, the most effective treatment, is converted to dopamine in the brain, replenishing the diminished neurotransmitter.
Dopamine agonists mimic dopamine's effects by stimulating dopamine receptors, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. Deep Brain Stimulation (DBS), such as the Medtronic Percept PC DBS system, involves implanting electrodes in specific brain regions to modulate neural activity.
This can significantly alleviate motor symptoms by restoring more normal patterns of brain activity. These treatments are crucial for improving the quality of life in PD patients by reducing symptoms like tremors, rigidity, and bradykinesia.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,049 Previous Clinical Trials
1,370,719 Total Patients Enrolled
United States Department of DefenseFED
901 Previous Clinical Trials
332,940 Total Patients Enrolled
Media Library
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.
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