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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 88
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Contact Information
Primary
Sandra L Kletzel, PhD BA
Sandra.Kletzel@va.gov
(708) 202-5735
Backup
Alexandria N Umbarger, BS
alexandria.umbarger@va.gov
(708) 998-8213
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 40
Treatments
Experimental: Group 1
Vagal nerve stimulation at an intensity under 10 units. Participants will self-administered at this intensity for 2 minutes each day over 4 weeks.
Experimental: Group 2
Vagal nerve stimulation at the highest intensity tolerated by the participant. Participants will self-administered at this intensity for 12 minutes each day over 4 weeks.
No_intervention: Group 3
This group will not receive any stimulation. Participants will receive their treatment as usual.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov