| NCT ID | NCT05487664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Auricular Stimulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2023-03-17 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this one-visit, randomized, double-blind, sham-controlled trial, we plan to use a novel concurrent transcutaneous auricular neurostimulation (tAN) paradigm during functional magnetic resonance imaging (fMRI) paradigm in 96 individuals to determine whether tAN administered to two cranial nerves simultaneously produces greater neurophysiologic effects than stimulating solely to the auricular branch of the vagus nerve (ABVN) or the auriculotemporal nerve (ATN; branch of trigeminal nerve) alone. Within the MRI scanner, each participant will be connected to a series of electrodes that stimulate 4 targets (ABVN only, ATN only, ABVN plus ATN, and Sham).
Eligibility Criteria
Inclusion Criteria: * Age 18-65 * Have the capacity and ability to provide one's own consent and sign the informed consent document Exclusion Criteria: * 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. * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05487664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Auricular Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05487664 currently recruiting?
Yes, NCT05487664 is actively recruiting participants. Contact the research team at badran@musc.edu for enrollment information.
Where is the NCT05487664 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05487664 clinical trial?
NCT05487664 is sponsored by Medical University of South Carolina. The trial plans to enroll 96 participants.