Using auricular stimulation to assess pain relief effects during MRI
Determining the Independent and Synergistic Effects of Transcutaneous Auricular Neurostimulation (tAN) on Direct Brain Activation in Healthy Individuals
This study is testing if a new way of stimulating certain nerves in the ear can help relieve pain during MRI scans for people with chronic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05487664 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who can provide informed consent and do not have contraindications for MRI.
Not a fit: Patients with untreated medical, neurological, or psychiatric conditions, or those with a history of severe headaches or substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a non-opioid treatment option for chronic pain management.
How similar studies have performed: Previous studies have shown promising results for auricular nerve stimulation in reducing opioid withdrawal symptoms and pain, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.