transcutaneous auricular nerve sti… for Parkinson's (NCT07536022)
Home ear stimulation improves balance
- Trial ID
- NCT07536022
- Official Title
- Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease
- Goal
- Home ear stimulation improves balance
- 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
Summary For Families
Researchers are testing whether at-home ear-based nerve stimulation, called transcutaneous auricular nerve stimulation or taVNS, can help treat Parkinson's symptoms, especially problems with walking, balance, and gait, and whether people can use the device safely and reliably at home. Participants will be trained to use a small earpiece that delivers stimulation, have an initial supervised session and brain scan, then do one-hour daily at-home sessions for eight weeks while researchers track completion rates, side effects, how people rate the sessions, changes on symptom and cognitive questionnaires, and changes in brain network connections on repeat brain scans. The study is enrolling people ages 40 to 85 with a diagnosis of Parkinson's who have walking or balance problems and are in disease stages 2 to 4, who are on stable Parkinson's medications and can undergo MRI and perform at-home procedures; people with seizures, recent brain surgery or stroke, significant cognitive impairment, certain heart problems, ear issues that prevent an earpiece fit, or MRI-incompatible implants are not eligible.
Locations
- Medical University of South Carolina, Charleston, South Carolina, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying transcutaneous auricular nerve stimulation. Researchers are testing whether at-home ear-based nerve stimulation, called transcutaneous auricular nerve stimulation or taVNS, can help treat Parkinson's symptoms, especially problems with walking, balance, and gait, and whether people can use the device safely and reliably at home. Participants will be trained to use a small earpiece that delivers stimulation, have an initial supervised session and brain scan, then do one-hour daily at-home sessions for eight weeks while researchers track completion rates, side effects, how people rate the sessions, changes on symptom and cognitive questionnaires, and changes in brain network connections on repeat brain scans. The study is enrolling people ages 40 to 85 with a diagnosis of Parkinson's who have walking or balance problems and are in disease stages 2 to 4, who are on stable Parkinson's medications and can undergo MRI and perform at-home procedures; people with seizures, recent brain surgery or stroke, significant cognitive impairment, certain heart problems, ear issues that prevent an earpiece fit, or MRI-incompatible implants 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?
- 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 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 taVNS session followed by 8 weeks of at-home taVNS 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.