Mastoid taVNS-fMRI

Not Applicable

Recruiting

• Conditions: Auricular Stimulation
• Interventions: Device: Transcutaneous Auricular Neurostimulation (tAN)

• Registration Number: NCT06518356
• Lead Sponsor: Medical University of South Carolina

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.

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 technique has been demonstrated effective in the treatment of depression and addiction in previous studies.

Most previous applications of taVNS targeted the ABVN via the cymba conchae or tragus sites. The mastoid process (mastoid site) is an important dermatome innervated by the ABVN, but there is currently a lack of knowledge on how taVNS on the mastoid site affects brain activity and whether it differs from the effect of stimulating the cymba site.

In this proposed study, the investigators plan to explore whether delivering taVNS to the mastoid site and the cymba site can induce different patterns of brain activity. Ultimately, if successful, this project will not only deepen our knowledge in basic neuroscience but also have great value in clinical applications since the mastoid site is a much more accessible ABVN target compared to other sites.

Study Timeline

• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15
• Study Start: 2024-08-20
• Primary Completion: 2025-07-02
• Study Completion: 2025-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Auricular Neurostimulation (Active 1)	Transcutaneous Auricular Neurostimulation (tAN)	•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)
Auricular Neurostimulation (Active 2)	Transcutaneous Auricular Neurostimulation (tAN)	•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)
Auricular Neurostimulation (Sham 1)	Transcutaneous Auricular Neurostimulation (tAN)	•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)

Primary Outcome Measures

Name	Time	Method
Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation	30 minutes	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.

Trial Locations

Locations (1)

Medical University of South Carolina Institute of Psychiatry; 🇺🇸 Charleston, South Carolina, United States