🏛️ Verified NIH Record • Updated 2026-07-07

Non-invasive VNS for Parkinson's Gait (NCT06562569)

Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: VA Office of Research and Development

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (18 items).

Location: Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois

Age range: 50 Years to 88 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: For Group 1 and 2
  • 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
  • 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).
  • Abnormal baseline electrocardiogram within last year
  • Previous vagotomy
  • Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS
  • Active cancer
  • have previously had cancer in any areas where stimulation will occur

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois

📞 Contact the Study Coordinator

Phone: (708) 202-5735

Email: Sandra.Kletzel@va.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗