Recruiting

Transcutaneous Vagal Nerve StimulationNon-invasive VNS for Parkinson's Gait

Sponsor:

VA Office of Research and Development

Code:

NCT06562569

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

non-invasive cervical vagal nerve stimulation ncVNS

Study Details

Brief 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.

Conditions

Parkinson's Disease

Study ID

NCT06562569

Start date

Mar 1, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

For Group 1 and 2

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
Uncontrolled hypertension, hypotension, bradycardia, or tachycardia
History of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure, known severe coronary artery disease, severe carotid stenosis (e.g., bruits or history of TIA or stroke), or recent myocardial infarction (within 5 years).
Abnormal baseline electrocardiogram within last year
Previous vagotomy
Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS
Active cancer
have previously had cancer in any areas where stimulation will occur
Documented abnormal cervical anatomy
History of brain tumor, aneurysm, bleed or head trauma
History of syncope or seizures (within the last 2 years)

For Group 3

Lack of decision-making capacity
Musculoskeletal or additional neurological conditions that negatively impact gait and balance
Spine or LE surgery within the past year

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

Stride Length [ Time Frame: baseline and 4 weeks ]

Central Contacts and Locations

Central contacts

Sandra L Kletzel, PhD BA

(708) 202-5735 Sandra.Kletzel@va.gov

Alexandria N Umbarger, BS

(708) 998-8213 alexandria.umbarger@va.gov

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

Sadie Walker, OTR

708-964-3805 sadie.walker@va.gov

Alexandria N Umbarger, BS

(708) 998-8213 alexandria.umbarger@va.gov

Principal Investigator:

Sandra L. Kletzel, PhD BA

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

vagal nerve stimulation
gait
neuromodulation
Freezing of gait
Veteran

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-09.