Non-invasive VNS for Parkinson's Gait

Summary

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.

Eligibility

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)

Conditions1

Locations1 site

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