transcutaneous auricular vagus ner… for Parkinson's (NCT07557706)
Ear stimulation reduces standing lightheadedness
- Trial ID
- NCT07557706
- Official Title
- Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease
- Goal
- Ear stimulation reduces standing lightheadedness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- transcutaneous auricular vagus nerve stimulation
Summary For Families
The goal is to see whether gentle electrical stimulation of the vagus nerve at the ear can improve autonomic control of heart rate and blood pressure in people with Parkinson's, which could help with issues like orthostatic hypotension. The approach uses transcutaneous auricular vagus nerve stimulation, a noninvasive method that sends mild pulses through the skin of the outer ear to activate the vagus nerve and increase parasympathetic activity, potentially improving heart rate variability and blood pressure regulation while people stay on their usual Parkinson's meds. They are looking for adults 18 to 80 with idiopathic Parkinson's who have been on stable medications for at least four weeks. People on beta blockers, with uncontrolled heart disease, recent heart attack, seizure history, severe cognitive impairment, or who are pregnant are not eligible.
Locations
- Wellness, Health and Research Facility at UAB, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying transcutaneous auricular vagus nerve stimulation. The goal is to see whether gentle electrical stimulation of the vagus nerve at the ear can improve autonomic control of heart rate and blood pressure in people with Parkinson's, which could help with issues like orthostatic hypotension. The approach uses transcutaneous auricular vagus nerve stimulation, a noninvasive method that sends mild pulses through the skin of the outer ear to activate the vagus nerve and increase parasympathetic activity, potentially improving heart rate variability and blood pressure regulation while people stay on their usual Parkinson's meds. They are looking for adults 18 to 80 with idiopathic Parkinson's who have been on stable medications for at least four weeks. People on beta blockers, with uncontrolled heart disease, recent heart attack, seizure history, severe cognitive impairment, or who are pregnant are not eligible.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.
- How many visits does this trial involve?
- At least 2 study visits (Visit 2 and Visit 3).
- Is there a medication washout in this trial?
- A minimum washout period of 48 hours will be observed between visits.