Non-invasive VNS for Parkinson's Gait
ConditionParkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-88
SponsorVA Office of Research and Development
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- non-invasive cervical vagal nerve stimulation ncVNS
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov