Actively Recruiting

Phase Not Applicable
Age: 21Years - 76Years
All Genders
Healthy Volunteers
ID07226284

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

Led by University of Minnesota · Updated on 2026-02-13

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Minnesota

Lead Sponsor

P

Parkinson's Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying people with Parkinson's disease (PD) to better understand why their leg muscles do not activate properly and to test if stimulating a nerve in the neck can improve muscle activation, walking, and balance. This study focuses on persistent inward currents (PICs) in spinal motoneurons controlling ankle muscles, which may be reduced in PD and linked to poor postural control. The trial also explores the immediate effects of non-invasive vagus nerve stimulation (nVNS) on these muscle activities and balance. The study includes 30 participants with PD (half with postural instability and gait difficulty and half without) and 15 matched healthy controls. Participants undergo sessions with no stimulation, real nVNS using a handheld device that stimulates the vagus nerve through electrodes on the neck, and sham nVNS where the device is inactive. These interventions are compared to assess changes in muscle firing and posture. Participants will be assessed for muscle activity and balance before, during, and after stimulation sessions, with follow-ups up to four weeks. Measurements include changes in muscle excitability, step length, force on the stepping leg, and sway during standing. The study tracks safety and effects through clinical evaluations and questionnaires, aiming to provide initial data for future larger trials of nVNS in PD.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 76Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 participants matched by age (± 3 years) and sex to the PD group
  • Control participants able to ambulate without the use of an assistive device for more than 50 meters
Not Eligible

You will not qualify if you...

  • Unable to demonstrate capacity to consent
  • History of significant neurological disorder besides PD
  • History of stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor, or atypical parkinsonian disorder
  • Severe orthopedic or musculoskeletal problems affecting gait
  • Women who are pregnant or may be pregnant
  • Insufficient English comprehension
  • History of substance abuse in past 2 years
  • Pain or lesions at the nVNS treatment site
  • Previous surgery or abnormal anatomy near the stimulation site
  • Severe cardiovascular or carotid artery disease
  • Abnormal ECG within the last year
  • Recent uncontrolled blood pressure or heart rate issues
  • Previous unilateral or bilateral vagotomy
  • Implanted metallic or electronic devices near stimulation site
  • History of syncope or seizures in last 2 years

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Within-session VNS: 0-60 minutes; Between VNS sessions: 1 to 4 weeks

Participants receive non-invasive vagus nerve stimulation (nVNS) or sham stimulation in a crossover design to study the effects on lower leg muscle activity and posture.

Multiple visits including baseline and treatment visits with nVNS and sham stimulation

Trial Site Locations

Total: 1 location

1

Movement Disorders Laboratory

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

P

Principal Investigator

K

Kristin Garland

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

How to identify tremor dominant and postural instability/gait difficulty groups with the movement disorder society unified Parkinson's disease rating scale: comparison with the unified Parkinson's disease rating scale.

Glenn T Stebbins, Christopher G Goetz, David J Burn...

https://pubmed.ncbi.nlm.nih.gov/23408503

Vagus nerve stimulation in Parkinson's disease: a scoping review of animal studies and human subjects research.

Alexandra Evancho, Melissa Do, Damiana Fortenberry...

https://pubmed.ncbi.nlm.nih.gov/39448636