Actively Recruiting
Non-invasive VNS for Parkinson's Gait
Led by VA Office of Research and Development · Updated on 2026-04-23
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.
CONDITIONS
Official Title
Non-invasive VNS for Parkinson's Gait
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parkinson's disease diagnosed by a VA neurologist
- Hoehn and Yahr stages 2-3
- Self-reported freezing of gait
- Able to walk for 2 minutes without using an assistive device
- Stable Parkinson's disease medications for at least 4 weeks and expected to remain stable during the study
You will not qualify if you...
- Lack of decision-making capacity
- Use of centrally acting anticholinergics or cholinesterase inhibitors
- Other musculoskeletal or neurological conditions affecting walking or balance
- Spine or lower extremity surgery within the past year
- Severe cardiovascular diseases including severe atherosclerosis, carotid artery disease, congestive heart failure, or severe coronary artery disease
- Abnormal electrocardiogram in the past year
- Previous vagotomy surgery
- Implanted metal cervical spine hardware or other metallic implants including deep brain stimulators
- History of fainting or seizures within the last 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
Research Team
S
Sandra L Kletzel, PhD BA
CONTACT
A
Alexandria N Umbarger, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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