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

February 10, 2026 updated by: University of Minnesota

The Effects of Vagus Nerve Stimulation on Intrinsic Lower Leg Spinal Motoneuron Excitability in Parkinson's Disease.

This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goals of this project are twofold: (i) to test the hypothesis that persistent inward currents (PICs) in spinal motoneurons of the ankle extensors are reduced in people with Parkinson's disease and that these changes are associated with impaired postural control and (ii) to examine the acute effects of non-invasive vagus nerve stimulation (nVNS) on PICs and postural control.

This project will conduct experiments to test the hypothesis that the firing properties of muscles that control the ankle are significantly altered in people with PD compared to matched healthy adults and that these changes in activity are related to the severity of postural control deficits. In addition, this project will examine the acute effects of non-invasive vagal nerve stimulation (nVNS), an intervention that increases activity in the locus coeruleus and raphe nucleus, on the firing properties of ankle muscles and postural control. If successful, this work will be the first to demonstrate that brainstem pathways that control muscle firing properties are altered in people with PD and are associated with postural impairment. The preliminary trial of nVNS will provide evidence that postural muscle activity can be improved with stimulation and improve postural control. These findings will provide critical preliminary data required to move forward with a clinical trial of nVNS in PD.

Study Type

Interventional

Enrollment (Estimated)

75

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

  • Name: Principal Investigator
  • Phone Number: 612-625-8938
  • Email: cmackinn@umn.edu

Study Contact Backup

  • Name: Kristin Garland
  • Phone Number: 612-505-6574

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • Movement Disorders Laboratory
        • 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

Yes

Description

Inclusion Criteria:

  • 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.

Control Cohort:

  • 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 Criteria:

  • 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;

Additional exclusion criteria for VNS experiment

  • 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);

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Baseline (no VNS)
Within-subject and cross-sectional design that consists of 30 participants with PD (15 with PIGD and 15 without PIGD) and 15 matched controls.
Other: No intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
Experimental: Real nVNS
Device: Vagal nerve stimulation
The gammaCore non-invasive vagus nerve stimulator (nVNS) is a hand-held portable device that is used to apply electrical stimulation to the vagus nerve via two electrodes.
Sham Comparator: Sham nVNS
Sham VNS will be applied using setting that do not active the vagus nerve.
Other: No intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in delta-F
Time Frame: Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.
Difference between baseline and post-VNS delta-F measure
Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Braceheight
Time Frame: Within-session VNS: 0 -60 minutes; between VNS sessions: 1-4 weeks
Change in brace height measure between before and after VNS
Within-session VNS: 0 -60 minutes; between VNS sessions: 1-4 weeks
Step length
Time Frame: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Average step length
Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Peak magnitude force on step leg
Time Frame: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
peak magnitude of the step leg loading force during gait initiation
Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Postural sway magnitude
Time Frame: Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks
Root mean square (RMS) of the center of pressure smoothness (jerk) in the medial-lateral plane.
Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks

Collaborators and Investigators

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

Sponsor

University of Minnesota

Collaborators

Parkinson's Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 10, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 5, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUR-2025-34303

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

Yes

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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