Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease (NCT07557706) | Clinical Trial Compass
RecruitingPhase 1
Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease
United States24 participantsStarted 2025-09-15
Plain-language summary
The purpose of this study is to find out whether a type of gentle nerve stimulation, called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the body regulates heart rate and blood pressure in people with Parkinson's Disease (PD). Problems with heart rate and blood pressure control are common and can make it harder for people to exercise or do daily activities. By using this non-invasive form of nerve stimulation and testing how it affects the body's natural responses, this study hopes to learn if taVNS could be a helpful tool to support physical therapy and improve overall function.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of idiopathic PD
* Stable medication for at least 4 weeks prior to the study
Exclusion Criteria:
* Use of beta blockers
* Sustained severe hypertension (\>/= 180/110 mmHg while seated)
* Significant uncontrolled cardiac arrhythmia
* Unstable angina
* Congestive heart failure
* History of myocardial infarction
* History of seizures
* Severe cognitive impairment
* Pregnant women or women who are planning to become pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing transcutaneous auricular vagus nerve stimulation — a device applied to the ear — to see if it can change heart rate and blood pressure in people with Parkinson's disease. Could you help me understand what that kind of stimulation actually involves and whether it would be safe given my specific heart or blood pressure history?
2Since this is a Phase 1 trial focused on measuring changes in heart rate and blood pressure, it sounds like the main goal is to understand safety and how the body responds rather than to treat Parkinson's symptoms directly — is that right, and what does that mean for what I might personally get out of participating?
3Parkinson's disease can affect the autonomic nervous system, which already influences heart rate and blood pressure — could stimulating the vagus nerve carry any particular risks for someone at my stage of Parkinson's, or with any other conditions I have?
4Before considering something like this trial, are there standard treatments for the cardiovascular or autonomic symptoms of my Parkinson's that I should try first, or would joining this study fit alongside my current treatment plan?
5What would my time commitment look like if I were to discuss enrolling — how many visits, what happens during the stimulation sessions, and are there any restrictions or monitoring requirements I should know about before deciding whether this fits my life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in heart rate
Timeframe: During Visit 2 and Visit 3 (1-2 weeks after baseline, with 48 hour wash-out between visits 2 and 3), during and following 15 minutes of stimulation.
2
Change in blood pressure
Timeframe: During Visit 2 and Visit 3 (1-2 weeks after baseline, with 48 hour wash-out between visits 2 and 3), during and following 15 minutes of stimulation.