Non-invasive vagus nerve stimulation to improve walking and balance in Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional trial will deliver non-invasive cervical vagal nerve stimulation (ncVNS) using a hand-held device that contacts the left side of the neck and can be self-administered at home. Participants are Veterans with Parkinson's disease (Hoehn & Yahr stages 2–3) who report freezing of gait and can ambulate for two minutes without an assistive device, and who are on stable Parkinson's medications. Key exclusions include implanted metallic or neuromodulation devices (e.g., DBS), severe cardiac or carotid disease, recent spine or lower-extremity surgery, cognitive impairment, or certain centrally acting medications. The pilot aims to generate preliminary data to inform larger VA efforts to reduce gait dysfunction, falls, and loss of independence in Veterans with PD.

Why it matters

Who can join: the full rules

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

Where it's running

• Edward Hines Jr. VA Hospital, Hines, IL
  Hines, Illinois, United States Recruiting

Study contacts

• Principal investigator: Sandra L. Kletzel, PhD BA — Edward Hines Jr. VA Hospital, Hines, IL
• Study coordinator: Sandra L Kletzel, PhD BA
• Email: Sandra.Kletzel@va.gov
• Phone: (708) 202-5735

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.