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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

PARKINSON DISEASE (Disorder)Parkinson's Disease (PD)nVNSVagus nerveVNSParkinson's diseasePDgammaCore

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

📊
1 of 75 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Minneapolis

Minnesota

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for PARKINSON DISEASE (Disorder) Treatment in Minneapolis?

Join others in Minnesota exploring innovative treatment options through clinical research

PARKINSON DISEASE (Disorder) Treatment Options in Minneapolis, Minnesota

If you're searching for PARKINSON DISEASE (Disorder) treatment in Minneapolis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Minneapolis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with PARKINSON DISEASE (Disorder). All study-related care is provided at no cost to participants.

Local Sites
1 locations in Minnesota
Now Enrolling
Up to 75 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for PARKINSON DISEASE (Disorder)?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for PARKINSON DISEASE (Disorder)

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This PARKINSON DISEASE (Disorder) Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07226284. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.