Using auricular stimulation to assess pain relief effects during MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effects of transcutaneous auricular neurostimulation (tAN) on pain relief by stimulating two cranial nerves simultaneously during functional magnetic resonance imaging (fMRI). In a randomized, double-blind, sham-controlled design, 96 participants will receive one of four types of stimulation: auricular branch of the vagus nerve (ABVN) only, auriculotemporal nerve (ATN) only, both ABVN and ATN, or a sham stimulation. The goal is to determine if combined stimulation produces greater neurophysiological effects compared to single nerve stimulation. This approach aims to provide an alternative to opioid use for chronic pain management.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of South Carolina Institute of Psychiatry
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Bashar Badran, PhD
• Email: badran@musc.edu
• Phone: 843-792-6076

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.