Non-invasive VNS for Parkinson's Gait
Recruiting · NCT06562569 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
1 location listed across 1 US state.
- Edward Hines Jr. VA Hospital, Hines, IL - Hines, Illinois, United States