Non-invasive vagus nerve stimulation to improve walking and balance in Parkinson's
Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease
This project will test whether a hand-held, at-home non-invasive vagus nerve stimulator can improve walking and reduce freezing of gait in Veterans with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 88 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Hines, Illinois) |
| Trial ID | NCT06562569 on ClinicalTrials.gov |
What this trial studies
This pilot interventional trial will deliver non-invasive cervical vagal nerve stimulation (ncVNS) using a hand-held device that contacts the left side of the neck and can be self-administered at home. Participants are Veterans with Parkinson's disease (Hoehn & Yahr stages 2–3) who report freezing of gait and can ambulate for two minutes without an assistive device, and who are on stable Parkinson's medications. Key exclusions include implanted metallic or neuromodulation devices (e.g., DBS), severe cardiac or carotid disease, recent spine or lower-extremity surgery, cognitive impairment, or certain centrally acting medications. The pilot aims to generate preliminary data to inform larger VA efforts to reduce gait dysfunction, falls, and loss of independence in Veterans with PD.
Who should consider this trial
Good fit: Ideal candidates are Veterans with Parkinson's disease (Hoehn & Yahr stage 2–3) who report freezing of gait, can walk for two minutes unaided, and are on stable PD medications.
Not a fit: Those with implanted cervical metal or neuromodulation devices (such as DBS), severe cardiovascular or carotid disease, recent spine/leg surgery, significant musculoskeletal or other neurologic gait impairments, cognitive impairment, or on excluded central anticholinergic or cholinesterase inhibitor medications are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could improve gait and balance, lower fall risk, and help Veterans with Parkinson's stay independent longer.
How similar studies have performed: Non-invasive cervical VNS is approved for migraine and small neuromodulation or invasive VNS studies suggest motor and anti-inflammatory effects, but its use specifically to improve Parkinson's gait remains largely unproven in large clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hines, Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Sandra L. Kletzel, PhD BA — Edward Hines Jr. VA Hospital, Hines, IL
- Study coordinator: Sandra L Kletzel, PhD BA
- Email: Sandra.Kletzel@va.gov
- Phone: (708) 202-5735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.