Non-invasive VNS for Parkinson's Gait

April 20, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. PD is a complex chronic neurodegenerative multisystem disorder. Fall prevention is a priority for Veterans living with PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. Gait abnormalities are evident at the time of PD diagnosis and are one of the most disabling features of PD. They are also difficult aspects to treat as pharmacologic agents do not address the entire spectrum of gait abnormalities. Overall management of PD symptoms can be challenging due to pharmacological interactions and drug side effects. Developing a non-pharmacological and non-invasive therapeutic to improve gait and balance is a critical need for Veterans with PD who are managing complex chronic conditions. Moreover, advancing at-home rehabilitation is ideal for a population of geriatric Veterans who are facing mobility issues, managing multiple chronic conditions and who rely on caregiver support. Non-invasive cervical Vagal Nerve Stimulation (ncVNS) may be a solution. ncVNS is currently licensed to treat and prevent migraine and other headache syndromes and is covered by the VAH for these indications. ncVNS can be self-administered, daily, at home. A hand-held device is used to make contact to the left side of the neck so that the vagal nerve is stimulated. ncVNS decreases inflammation and oxidative stress through activation of the cholinergic anti-inflammatory pathway, which in turn can contribute to gait improvements in PD. One of the most debilitating gait deficits in PD is Freezing of Gait (FOG), an episodic failure to initiate or maintain walking, especially while turning. Given that FOG, along with falls, is related to cholinergic dysfunction, both might be reduced following ncVNS. Exciting, but limited research over the past decade indicates this neuromodulatory approach has the potential to improve gait features in PD. The objectives of this SPiRE are to develop a framework for an at-home ncVNS intervention, develop an appropriate control intervention for a future larger study and gather preliminary clinical outcome data on PD-specific features. The central hypotheses are that (i) a 4 week at-home active ncVNS intervention and a sham ncVNS control condition will be acceptable and feasible to complete and (ii) active ncVNS compared to both control ncVNS and treatment as usual (TAU), will lead to greater improvements in gait, FOG, balance and fall frequency. The proposed study is a pilot, prospective parallel group randomized control trial (RCT). Twenty participants will be randomized to 4 weeks of either active (n=10) or sham ncVNS (n=10). A third group (n=10) will not receive ncVNS but will continue with their treatment as usual (TAU). The investigators will examine acute, cumulative, and sustainable effects of ncVNS. Advancing non-pharmacologic treatments to improve gait dynamics is a critical need for Veterans with PD. Moreover, advancing at-home rehabilitation is ideal for a population of geriatric Veterans who are facing multiple issues including mobility. This SPiRE is strongly aligned with VA priorities to advance rehabilitative health care of Veterans and restore their physical function to improve QoL. If the aims are achieved, the investigators will have completed necessary first steps towards developing an at-home easy to use, neuromodulatory intervention that should translate to improved gait and balance and contribute to fewer falls. This project will yield preliminary data to support a VA Merit and move forward not only the field of noninvasive and nonpharmacological interventions for PD rehabilitation but also the general field of gait and balance rehabilitation.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Hines, Illinois, United States, 60141-3030
        • Recruiting
        • Edward Hines Jr. VA Hospital, Hines, IL
        • Principal Investigator:
          • Sandra L. Kletzel, PhD BA
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

  • Known or suspected:

    • severe atherosclerotic cardiovascular disease
    • severe carotid artery disease
    • congestive heart failure
    • known severe coronary artery disease or prior myocardial infarction
  • Abnormal baseline electrocardiogram within last year
  • Previous vagotomy
  • Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS
  • History of syncope or seizures (within the last 2 years)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • VNS
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.
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.
Other Names:
  • VNS
No Intervention: Group 3
This group will not receive any stimulation. Participants will receive their treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride Length
Time Frame: baseline and 4 weeks
Quantitative gait analysis will be performed during a 15-meter instrumented 2-min walk test (2MWT) using the APDM Mobility Lab
baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Sandra L. Kletzel, PhD BA, Edward Hines Jr. VA Hospital, Hines, IL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E5133-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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