Non-invasive VNS for Parkinson's Gait (NCT06562569) | Clinical Trial Compass
RecruitingNot Applicable
Non-invasive VNS for Parkinson's Gait
United States40 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
50 Years – 88 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.