Recruiting

Nerve Stimulation

Sponsor:

University of Minnesota

Code:

NCT07226284

Conditions

PARKINSON DISEASE (Disorder)

Parkinson's Disease (PD)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Vagal nerve stimulation

No intervention

Study Details

Brief summary:

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.

Conditions

PARKINSON DISEASE (Disorder)

Parkinson's Disease (PD)

Study ID

NCT07226284

Start date

Feb 10, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Real nVNS

sham comparator: Sham nVNS

Sham VNS will be applied using setting that do not active the vagus nerve.

Interventions

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.

No intervention

No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two

Primary outcome measure

  • Change in delta-F [ Time Frame: Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks. ]

Central Contacts and Locations

Central contacts

Principal Investigator

612-625-8938cmackinn@umn.edu

Kristin Garland

612-505-6574

Locations

Movement Disorders Laboratory

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Kristin Garland

612-505-6574garl0038@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • nVNS
  • Vagus nerve
  • VNS
  • Parkinson's disease
  • PD
  • gammaCore

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-02-13.