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Non-invasive VNS for Parkinson's Gait

This study is investigating a non-invasive cervical vagal nerve stimulation (ncVNS) device to help improve walking difficulties (gait) in people with Parkinson's disease. The ncVNS device is a small, handheld device that delivers a gentle electrical stimulus. Researchers want to see if using this device at home can help people with Parkinson's walk better and reduce their risk of falls. You may be able to join if you are a Veteran aged 50-88, have Parkinson's disease (stages 2-3), experience freezing of gait, and can walk for two minutes without help. Your Parkinson's medications must also be stable. The study will measure stride length to see if the device is successful. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It will test the ncVNS device.
What's involved
Participants will have their stride length measured at the beginning of the study and again after 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 4 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06562569

Non-invasive VNS for Parkinson's Gait

Recruiting
NAAges 50–88InterventionalTreatment
VA Office of Research and Development
~40 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:non-invasive cervical vagal nerve stimulation ncVNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stride Length
Measured over baseline and 4 weeks

Conditions

Parkinson's Disease

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NCT06562569

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sandra L. Kletzel, PhD BA · PRINCIPAL_INVESTIGATOR · Edward Hines Jr. VA Hospital, Hines, IL

Who to contact

Sandra L Kletzel, PhD BA
[email protected]
(708) 202-5735
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Stride Lengthbaseline and 4 weeks

    Quantitative gait analysis will be performed during a 15-meter instrumented 2-min walk test (2MWT) using the APDM Mobility Lab