Non-invasive VNS for Parkinson's Gait

Part of paid clinical trials in Hines, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT06562569
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • non-invasive cervical vagal nerve stimulation ncVNS — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Stride Length [ Time Frame: baseline and 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Sadie Walker, OTR
[email protected]
((70) 964-3805
Alexandria N Umbarger, BS
[email protected]
(708) 998-8213
Sandra L. Kletzel, PhD BA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hines, IL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Edward Hines Jr. VA Hospital, Hines, IL· Hines, IL

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