Vagus nerve stimulation to improve ankle muscle activity and posture in Parkinson's disease
The Effects of Vagus Nerve Stimulation on Intrinsic Lower Leg Spinal Motoneuron Excitability in Parkinson's Disease.
This project will test whether non-invasive vagus nerve stimulation at the neck can improve ankle muscle activation, walking, and balance in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years to 76 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07226284 on ClinicalTrials.gov |
What this trial studies
The study compares firing properties of ankle extensor motor units and persistent inward currents (PICs) in people with Parkinson's disease versus age- and sex-matched healthy adults. Researchers will record muscle activity and postural responses during standing and walking tasks to link changes in PICs to postural control deficits. The protocol includes acute non-invasive vagus nerve stimulation (nVNS) at the neck to determine whether stimulation modifies PICs and improves muscle activation and balance. Results will provide preliminary physiological and clinical data to support larger clinical trials if nVNS shows beneficial effects.
Who should consider this trial
Good fit: Ideal candidates are adults with idiopathic Parkinson's disease who can walk more than 50 meters without an assistive device, are on stable medications, and can provide informed consent in English.
Not a fit: People with atypical parkinsonian disorders, recent stroke or traumatic brain injury, severe musculoskeletal gait limitations, significant cognitive impairment, pregnancy, or recent substance abuse are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, nVNS could become a non-invasive option to improve ankle muscle activation and reduce balance problems and fall risk in people with Parkinson's disease.
How similar studies have performed: Non-invasive VNS has produced promising physiological signals in preclinical work and small human studies for other conditions, but it remains unproven for improving postural control in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minneapolis, Minnesota
- Movement Disorders Laboratory — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Principal Investigator
- Email: cmackinn@umn.edu
- Phone: 612-625-8938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.