Vagus nerve stimulation to improve ankle muscle activity and posture in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Movement Disorders Laboratory
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Principal Investigator
• Email: cmackinn@umn.edu
• Phone: 612-625-8938

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.