Exploring ear stimulation effects on brain activity
Investigating the Direct Brain Effects of Activating the Auricular Branch of the Vagus Nerve from the Cymba Concha or Mastoid Process: a Sham-controlled FMRI Study
This study is testing how ear stimulation affects brain activity in healthy people to see if it could lead to new treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06518356 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on different parts of the ear, specifically the mastoid and cymba sites, to observe variations in brain activation patterns. A total of 24 healthy participants will undergo non-invasive ear stimulation while their brain activity is monitored using MRI technology. The research aims to enhance understanding of how taVNS affects brain function and could lead to more accessible treatment options in clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-65 who can provide informed consent in English.
Not a fit: Patients with untreated medical, neurological, or psychiatric conditions, or those with contraindications for MRI, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective and accessible neuromodulation techniques for various neurological conditions.
How similar studies have performed: Previous studies have shown success with taVNS targeting other sites, but the mastoid site remains relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 * Have the capacity and ability to provide one's own consent in English and sign the informed consent document. Exclusion Criteria: * Unable to speak in English. * Contraindicated for MRI. * Any current or recent untreated medical, neurological, or psychiatric conditions * Metal implant devices in the head, heart or neck. * History of brain surgery. * History of myocardial infarction or arrhythmia, bradycardia. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium). * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury. * Participant has abnormal ear anatomy, skin irritation, or ear infection present * Individuals suffering from frequent/severe headaches. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic. * Moderate to severe alcohol or substance use disorder. * Pregnancy
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Institute of Psychiatry — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Xiaolong Peng — Medical University of South Carolina
- Study coordinator: Falon Sutton
- Email: suttonf@musc.edu
- Phone: 843-792-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.