Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT05487664

Conditions

Auricular Stimulation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcutaneous Auricular Neruostimulation (tAN)

Study Details

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).

Conditions

Auricular Stimulation

Study ID

NCT05487664

Start date

Mar 17, 2023

Status verified date

Dec, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Auricular Neurostimulation (Active 1)

•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target

-ABVN Only stimulation (15Hz stimulation of cymba conchae)

active comparator: Auricular Neurostimulation (Active 2)

•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target

-ATNS Only stimulation (100Hz stimulation of the tragus)

active comparator: Auricular Neurostimulation (Active 3)

•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target

-Combo stimulation (stimulation of both the 15Hz cymba conchae and 100HZ tragus)

sham comparator: Auricular Neurostimulation (Sham 1)

•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target

-Sham (15Hz stimulation of the earlobe)

sham comparator: Auricular Neurostimulation (Sham 2)

•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target

-Sham (100Hz stimulation of the earlobe)

Interventions

Transcutaneous Auricular Neruostimulation (tAN)

The intervention we are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets both the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN, a branch of the trigeminal nerve).

Primary outcome measure

  • BOLD signal changes during stimulation relative to no stimulation [ Time Frame: During tAN ]

Central Contacts and Locations

Central contacts

Bashar Badran, PhD

843-792-6076badran@musc.edu

Locations

Medical University of South Carolina Institute of Psychiatry

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Bashar W Badran, PhD

843-792-6076badran@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-12-18.