Status:
COMPLETED
Mastoid taVNS-fMRI
Lead Sponsor:
Medical University of South Carolina
Conditions:
Auricular Stimulation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS...
Detailed Description
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that delivers electric stimulation to the auricular branch of the vagus nerve (ABVN). This techniqu...
Eligibility Criteria
Inclusion
- Age 18-65
- Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06518356
Start Date
August 26 2024
End Date
April 28 2025
Last Update
July 4 2025
Active Locations (1)
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1
Medical University of South Carolina Institute of Psychiatry
Charleston, South Carolina, United States, 29425