Status:
NOT_YET_RECRUITING
Non-invasive VNS for PD Gait
Lead Sponsor:
VA Office of Research and Development
Conditions:
Parkinson's Disease
Eligibility:
All Genders
50-88 years
Phase:
NA
Brief Summary
More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances a...
Detailed Description
More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. PD is a complex chronic neurodegenerative multisystem disorder. Fall prev...
Eligibility Criteria
Inclusion
- Parkinson's disease, as diagnosis by a VA neurologist
- HY stages 2-3
- Self-report Freezing of Gait
- Able to ambulate for 2-min without an assistive device
- Parkinson's disease medications are stable for 4-weeks and expected to be on stable medications for duration of the study
Exclusion
- Lack of decision-making capacity
- Prescribed centrally acting anticholinergics (e.g., amitriptyline) or cholinesterase inhibitors
- Musculoskeletal or additional neurological conditions that negatively impact gait and balance
- Spine or LE surgery within the past year
- Known or suspected:
- severe atherosclerotic cardiovascular disease
- severe carotid artery disease
- congestive heart failure
- known severe coronary artery disease or prior myocardial infarction
- Abnormal baseline electrocardiogram within last year
- Previous vagotomy
- Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS
- History of syncope or seizures (within the last 2 years)
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06562569
Start Date
January 5 2026
End Date
April 1 2027
Last Update
October 22 2025
Active Locations (1)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030