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Non-invasive VNS for Parkinson's Gait

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 88 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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: 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 * Documented abnormal cervical anatomy * History of brain tumor, aneurysm, bleed or head trauma * History of syncope or seizures (within the last 2 years) For Group 3 * Lack of decision-making capacity * Musculoskeletal or additional neurological conditions that negatively impact gait and balance * Spine or LE surgery within the past year

Study sites (1)

IL