Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT05972759
Eligibility Criteria:
Inclusion Criteria:
* Adult with a diagnosis of PD by a movement disorders neurologist
* Previous placement, at least six months, of bilateral Medtronic Precept DBS as standard of care treatment for their PD.
* Stable and clinically optimized DBS parameters for three months prior to enrollment.
* Demonstrate the ability to safely mount and dismount a recumbent exercise cycle with an upright back.
* Willingness to withhold antiparkinsonian medication and DBS stimulation.
* Exercise clearance using the American College of Sports Medicine (ACSM) Pre-participation Health Screen: a. If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation; b. Those who choose not to obtain physician clearance will not be eligible for participation.
Exclusion Criteria:
* Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent.
* A musculoskeletal issue that limits one's ability to cycle
* Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke) that impacts motor or cognitive function
* Uncontrolled cardiovascular risk factor such as a current cardiac arrhythmia, uncontrolled hypertension, untreated deep vein thrombosis, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05972759
Study Brief:
Protocol Section:
NCT05972759