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Vagal Nerve Stimulation for Leg Muscle Activity and Posture in Parkinson's Disease

This study is investigating how Parkinson's disease (PD) affects leg muscle activity and balance. Researchers want to see if stimulating a nerve in the neck, called the vagus nerve, can improve these issues. They are using a hand-held device called gammaCore non-invasive vagus nerve stimulator (nVNS) to deliver electrical stimulation. The study aims to understand if changes in muscle firing properties are linked to balance problems in PD and if nVNS can improve them. You may be eligible if you have idiopathic Parkinson's disease, are on stable medication, and can walk over 50 meters without assistance. The study plans to enroll 75 participants. The main goal is to measure changes in leg muscle activity within minutes of stimulation and over 1 to 4 weeks.

Study design
This is an interventional study with planned enrollment of 75 participants. It will compare the effects of vagal nerve stimulation to no intervention or sham stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in muscle activity within 0-60 minutes of stimulation and between 1-4 weeks after stimulation sessions.

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

NCT07226284

Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease

Recruiting
NAAges 21–76InterventionalTreatment
University of Minnesota
~75 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Vagal nerve stimulationNo intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in delta-F
Measured over Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.

Conditions

PARKINSON DISEASE (Disorder)
Parkinson's Disease (PD)

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Parkinson Disease

NCT07226284

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.

  • Movement Disorders Laboratory

    Minneapolis, Minnesotastudy 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.

Who to contact

Principal Investigator
[email protected]
612-625-8938
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of idiopathic Parkinson's disease,
On stable medication for the preceding month and anticipated over the next 3 months,
Able to ambulate without the use of an assistive device for more than 50 meters.
Age (± 3 years) and sex distribution matched to the PD cohort,
Able to ambulate without the use of an assistive device for more than 50 meters.

Exclusion

Failure to demonstrate capacity to consent (based on UBACC and/or MacArthur-CR),
History of significant neurological disorder (besides PD in the PD group),
History of stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor or atypical parkinsonian disorder,
Severe orthopedic or other related musculoskeletal pathology that has significant adverse effects on gait,
Women who are pregnant or may be pregnant,
Insufficient comprehension of the English language,
History of substance abuse in past 2 years;
Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia);
Lesion (including lymphadenopathy), previous surgery (including carotid endarterectomy or vascular neck surgery) or abnormal anatomy at the stimulation site (open wound, rash, infection, swelling, cut, sore, drug patch, surgical scar\[s\]);
Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g., bruits or history of TIA or stroke), congestive heart failure, known severe coronary artery disease or prior myocardial infarction;
Abnormal baseline electrocardiogram (ECG) within the last year (e.g., second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation);
Recent history of uncontrolled high blood pressure, bradycardia, tachycardia, or know recent history orthostatic hypotension;
Previous unilateral or bilateral vagotomy;
Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as deep brain stimulator, hearing aid implant, pacemaker, implanted cardioverter defibrillator, cranial aneurysm and/or cranial aneurysm clips, history of facial/orbital/metallic fragments, implanted electronic device, neurostimulator, valve replacements/stents, metallic implants/prostheses) near the stimulation site such as a bone plate or bone screw;
History of syncope or seizures (within the last 2 years);

What this trial measures

  • Change in delta-FWithin-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.

    Difference between baseline and post-VNS delta-F measure