Non-Invasive Vagal Nerve Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen bySandra L. Kletzel, PhD BA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Sandra L. Kletzel, PhD BA

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

This trial is for US Veterans with Parkinson's Disease who experience gait disturbances, which can lead to falls and decreased independence. The goal is to help them improve their walking and balance through a non-drug treatment that they can use at home.

Inclusion Criteria

My Parkinson's medication has been stable for 4 weeks and will remain so during the study.

I experience sudden stops when I walk.

I have been diagnosed with Parkinson's disease by a VA neurologist.

See 2 more

Exclusion Criteria

I am unable to make my own health care decisions.

I have not had spine or leg surgery in the last year.

I am taking medication for nerve-related symptoms or memory issues.

See 9 more

Treatment Details

Interventions

Non-invasive cervical vagal nerve stimulation (ncVNS) (Neuromodulation)

Trial OverviewThe intervention being tested is a non-invasive cervical vagal nerve stimulation (ncVNS) device. This pilot clinical trial aims to see if using this device at home can help improve gait and balance in veterans with Parkinson's Disease.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 2Experimental Treatment1 Intervention

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.

Group II: Group 1Experimental Treatment1 Intervention

Vagal nerve stimulation at an intensity under 10 units. Participants will self-administered at this intensity for 2 minutes each day over 4 weeks.

Group III: Group 3Active Control1 Intervention

This group will not receive any stimulation. Participants will receive their treatment as usual.