Neck zap may ease Parkinson's leg stiffness
NCT ID NCT07226284
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a handheld device that gently stimulates the vagus nerve in the neck can improve leg muscle control, walking, and balance in people with Parkinson's disease. Researchers will compare real stimulation to a sham (fake) version in 75 participants. The goal is to understand if this non-invasive approach can help with movement problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- non-invasive vagus nerve stimulator (gammaCore nVNS)
- What this could lead to
- If it works, this could point toward a drug-free way to improve walking and balance in Parkinson's disease.
- What could go wrong
- This is an early-stage, small study (75 people) focused on short-term effects. It may not lead to lasting benefits or work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 76 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Movement Disorders Laboratory
RECRUITINGMinneapolis, Minnesota, 55414, United States
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