Effects of Vagal Nerve Stimulation on Leg 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.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 76 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at why people with Parkinson’s disease have trouble using their leg muscles. It tests whether stimulating a nerve in the neck can improve muscle use, walking, and balance. It includes people with Parkinson’s disease and a comparison group.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For the Parkinson’s group: have idiopathic Parkinson’s disease, meaning its cause is unknown.
- For the Parkinson’s group: medicines have been stable for the past month and are expected to stay stable for the next 3 months.
- For both groups: can walk more than 50 meters without a cane, walker, or other walking aid.
- For the comparison group: match the Parkinson’s group in age, within 3 years, and in the mix of sexes.
Who can't join
- Cannot show that you understand and can consent to the study, or do not understand enough English.
- Have a major brain or nerve disorder other than Parkinson’s in the Parkinson’s group. This includes stroke, brain injury, a bulging blood vessel or bleeding in the brain, brain tumor, or a different disorder like Parkinson’s.
- Have severe bone, joint, or muscle problems that greatly affect walking; are pregnant or may be pregnant; or have had substance abuse in the past 2 years.
- For the nerve stimulation test: have pain, skin damage, swollen glands, unusual body structure, past surgery, a scar, or a drug patch at the neck treatment site.
- For the nerve stimulation test: have known or suspected severe heart or artery disease, heart failure, or a past heart attack.
- For the nerve stimulation test: have an abnormal heart electrical test in the past year, or recent uncontrolled high blood pressure, slow or fast heartbeat, or blood pressure that drops when standing.
- For the nerve stimulation test: have had surgery to cut one or both vagus nerves, or have metal hardware, metal fragments, or an implanted medical device covered by the study’s restrictions.
- For the nerve stimulation test: have had fainting or seizures within the past 2 years.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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);
Study sites (1)
MN
- Movement Disorders Laboratory · Minneapolis, MN 55414Kristin Garland · Study contact · 612-505-6574 · garl0038@umn.eduMore trials in Minneapolis