RM1 Project 2 - tAN fMRI

NCT05487664 | Recruiting DMC

• 1 other identifier: Pro00122682
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• BOLD signal changes during stimulation relative to no stimulation

  . tAN will will be administered to participants within the bore of the MRI scanner while we acquire high resolution functional neuroimaging. Both a general linear model and SNM approach will be used to examine BOLD signal changes during stimulation relative to rest blocks, comparing each of the four stimulation targets within- and between subjects to determine whether stimulating two cranial nerves produces a more robust neurophysiological effect than either single nerve or sham stimulation alone.

  During tAN

Study Arms (5)

Auricular Neurostimulation (Active 1)

ACTIVE COMPARATOR

•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)

Device: Transcutaneous Auricular Neruostimulation (tAN)

Auricular Neurostimulation (Active 2)

ACTIVE COMPARATOR

•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)

Device: Transcutaneous Auricular Neruostimulation (tAN)

Auricular Neurostimulation (Active 3)

ACTIVE COMPARATOR

•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)

Device: Transcutaneous Auricular Neruostimulation (tAN)

Auricular Neurostimulation (Sham 1)

SHAM COMPARATOR

•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)

Device: Transcutaneous Auricular Neruostimulation (tAN)

Auricular Neurostimulation (Sham 2)

SHAM COMPARATOR

•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)

Device: Transcutaneous Auricular Neruostimulation (tAN)

Interventions

Transcutaneous Auricular Neruostimulation (tAN) DEVICE

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).

Auricular Neurostimulation (Active 1); Auricular Neurostimulation (Active 2); Auricular Neurostimulation (Active 3); Auricular Neurostimulation (Sham 1); Auricular Neurostimulation (Sham 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Have the capacity and ability to provide one's own consent and sign the informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29425, United States

RECRUITING

Central Study Contacts

Bashar Badran, PhD

CONTACT

843-792-6076; badran@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: March 17, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)