RM1 Project 2 - tAN fMRI
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Auricular Stimulation
In brief
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).
Key facts
- Study ID
- NCT05487664
- Run by
- Medical University of South Carolina
- People needed
- 96
- Starts
- 2023-03-17
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Medical University of South Carolina Institute of Psychiatry — Charleston, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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