Non-invasive VNS for PD Gait
Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease
VA Office of Research and Development
40 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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)
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Interventions
The ncVNS device is a rechargable, handheld device that generate a proprietary frequency-modulated electrical stimulus at low voltage (max 24V) with a max current output of 60mA. The signal consists of 1ms bursts of 5kHz sine waves repeated at 25Hz. Two stainless steel contact surfaces coated with conductive gel deliver the stimulus to the neck in the vicinity of the vagus nerve.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06562569