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RECRUITING
NCT06562569
NA

Non-invasive VNS for PD Gait

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 88 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2027-04-01

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DEVICE

non-invasive cervical vagal nerve stimulation ncVNS

The ncVNS device is a rechargable, handheld device that generate a proprietary frequency-modulated electrical stimulus at low voltage (max 24V) with a max current output of 60mA. The signal consists of 1ms bursts of 5kHz sine waves repeated at 25Hz. Two stainless steel contact surfaces coated with conductive gel deliver the stimulus to the neck in the vicinity of the vagus nerve.

Locations (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States