NCT06562569Recruiting
Non-invasive VNS for Parkinson's Gait
Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Aug 2024
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Parkinson disease
- NCT number
- NCT06562569
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Mar 2026 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prescribed centrally acting anticholinergics (e.g., amitriptyline) or cholinesterase inhibitors
- Spine or LE surgery within the past year
- Previous vagotomy
- Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS
- have previously had cancer in any areas where stimulation will occur
- Spine or LE surgery within the past year
Other illness
- Musculoskeletal or additional neurological conditions that negatively impact gait and balance
- Uncontrolled hypertension, hypotension, bradycardia, or tachycardia
- History of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure, known severe coronary artery disease, severe carotid stenosis (e.g., bruits or history of TIA or stroke), or recent myocardial infarction (within 5 years).
- Active cancer
- History of brain tumor, aneurysm, bleed or head trauma
- History of syncope or seizures (within the last 2 years)
- For Group 3
- Musculoskeletal or additional neurological conditions that negatively impact gait and balance
Other
- For Group 1 and 2
- Lack of decision-making capacity
- Abnormal baseline electrocardiogram within last year
- Documented abnormal cervical anatomy
- Lack of decision-making capacity
Who the study is looking for
- 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
Age in the registry: 50 years to 88 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL Coordinator of this site? Confirm its status | Hines | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.