transcutaneous auricular nerve sti… for Parkinson's (NCT07536022)

Can ear stimulation improve walking

Trial ID
NCT07536022
Official Title
Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease
Goal
Can ear stimulation improve walking
Phase
NA
Status
RECRUITING
Sponsor
Medical University of South Carolina
Study Type
INTERVENTIONAL
Enrollment
16 participants
Conditions
Parkinson's Disease
Interventions
transcutaneous auricular nerve stimulation
Registry Record Last Updated
2026-06-15 (1 month ago)
Estimated Commitment
Lower commitment estimated from the protocol (based on: 8 study visits). This reflects time and procedures only — confirm details with the study coordinator.

Summary For Families

Researchers are testing whether gentle electrical stimulation of the ear, called transcutaneous auricular nerve stimulation (taVNS), can help Parkinson's symptoms and whether people can use the device at home; they will also look at how the stimulation changes connections between brain networks on brain scans. Participants will have a baseline brain scan and symptom tests, be trained and given a supervised session to find a comfortable stimulation level, then self-administer one-hour daily ear stimulation at home for 8 weeks with weekly check-ins and repeat scans and questionnaires during and after treatment. The study is looking for adults 40 to 85 with diagnosed Parkinson's who have walking and balance problems and are in mid-stage disease (stage 2 to 4), and who have been on stable Parkinson's medications for at least 30 days. People with recent ear stimulation, prior brain surgery or stroke, certain heart problems or seizures, significant cognitive impairment, pregnancy, or who cannot safely do the home procedures are not eligible.

Eligibility at a Glance

Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.

  • Disease stage: Hoehn and Yahr stage 2 to 4
  • Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "Stable on dopaminergic medications over the past 30 days prior to enrollment in the study")
  • Thinking test (MoCA): MoCA memory and thinking score of at least 24 (criteria text: "Individuals with a diagnosis of cognitive impairment (MoCA \< 24) that would make them unable to understand and follow study instructions or to consent for themselves.")

Do I Likely Qualify? — Self-Check Dimensions

The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.

  • This trial enrolls people aged 40 to 85.
  • This trial requires Hoehn and Yahr stage 2 to 4.
  • This trial requires a MoCA thinking-test score of at least 24.

Locations

  • Medical University of South Carolina, Charleston, South Carolina, United States

Making Contact: How to Call This Study Site

Who to ask for

Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.

What to say

It is fine to read this out loud, word for word:

Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07536022. It is the one about "Can ear stimulation improve walking". Could I speak with the study coordinator about taking part?

If you are calling for a family member, use their name and mention that you help with their care.

What they will ask you

  • The year of diagnosis
  • Current medications and their doses
  • Other health conditions
  • Any procedures already done, such as deep brain stimulation (DBS)
  • How far you are able to travel for study visits
  • Whether a care partner can come to visits with you

What to have ready

  • A written list of current medications and doses
  • Your neurologist's name and phone number
  • The diagnosis date. The year is enough.
  • A recent visit summary from the neurologist, if you have one

What to ask them

  • How many visits are there, and how long does each visit take? The listing already answers this: One in-person session followed by 8 weeks of at-home sessions. Ask the coordinator to confirm it still applies.
  • Is travel, parking, or my time reimbursed?
  • Is there a placebo group, and what is my chance of being in it? The listing already answers this: Everyone in this trial receives the experimental treatment. There is no placebo group. Ask the coordinator to confirm it still applies.
  • Would I need to stop or pause any of my current medications?
  • What happens when the study ends? Could I stay on the treatment if it helps?

What to expect

  • Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
  • Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
  • Asking questions commits you to nothing. You can stop the process at any point.

Frequently Asked Questions

What is this trial testing?
This trial is studying transcutaneous auricular nerve stimulation. Researchers are testing whether gentle electrical stimulation of the ear, called transcutaneous auricular nerve stimulation (taVNS), can help Parkinson's symptoms and whether people can use the device at home; they will also look at how the stimulation changes connections between brain networks on brain scans. Participants will have a baseline brain scan and symptom tests, be trained and given a supervised session to find a comfortable stimulation level, then self-administer one-hour daily ear stimulation at home for 8 weeks with weekly check-ins and repeat scans and questionnaires during and after treatment. The study is looking for adults 40 to 85 with diagnosed Parkinson's who have walking and balance problems and are in mid-stage disease (stage 2 to 4), and who have been on stable Parkinson's medications for at least 30 days. People with recent ear stimulation, prior brain surgery or stroke, certain heart problems or seizures, significant cognitive impairment, pregnancy, or who cannot safely do the home procedures are not eligible.
Who can participate?
Participants must be between 40 Years and 85 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
How long does the trial last?
This trial is estimated to last approximately 1 year.
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?
Everyone in this trial receives the experimental treatment. There is no placebo group.
How many visits does this trial involve?
One in-person session followed by 8 weeks of at-home sessions.
What procedures are involved in this trial?
Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov