NCT07226284 · University of Minnesota
Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease
What this study is about
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.
View original scientific description
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.
Interventions
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.
OTHER
No intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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);
Where
- Minneapolis, Minnesota
Collaborators
Parkinson's Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations