Mastoid taVNS-fMRI

NCT06518356 | Completed

• 1 other identifier: Pro00137424
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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) will create different brain activation images. Investigators will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.

Conditions

Auricular Stimulation

Keywords

Healthy Volunteer Studies

Outcome Measures

Primary Outcomes (1)

• Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation

  taVNS will be administered to participants within the bore of the MRI scanner while the investigators 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 3 stimulation targets within- and between- subjects to identify any differences in brain activity during stimulation of the mastoid site compared to the cymba site and sham site.

  30 minutes

Study Arms (3)

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 -Cymba stimulation (15Hz stimulation of cymba conchae)

Device: Transcutaneous Auricular Neurostimulation (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 -Mastoid stimulation (15Hz stimulation of mastoid process)

Device: Transcutaneous Auricular Neurostimulation (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 Neurostimulation (tAN)

Interventions

Transcutaneous Auricular Neurostimulation (tAN) DEVICE

The intervention the investigators are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae and mastoid process, and to a sham site (earlobe).

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

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 in English and sign the informed consent document.

You may not qualify if:

• 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

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

Location

Study Officials

• Xiaolong Peng

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Instructor-Faculty

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: August 26, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)