Determining the Independent and Synergistic Effects of Transcutaneous Auricular Neurostimulation (tAN) on Direct Brain Activation in Healthy Individuals
Medical University of South Carolina
Summary
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).
Description
The demand for chronic pain treatment has demonstrated an unprecedented increase over the last several decades, in part contributing to an unsustainable surge in opioid prescriptions. Countless patients were escalated to prolonged, high-dose opioid regimens over years of treatment. By 2014, 5.4% of US adults were estimated to use prescription opioids on a long-term basis. As the harms of opioid proliferation became increasingly clear, a dramatic paradigm shift occurred in which these drugs came to be seen as often more dangerous than beneficial for chronic pain. New clinical guidelines highlig…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 o…
Interventions
- DeviceTranscutaneous Auricular Neruostimulation (tAN)
The intervention we are studying is called transcutaneous auricular neurostimulation (tAN). tAN is simply electrical nerve stimulation administered at the ear which targets both the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN, a branch of the trigeminal nerve).
Location
- Medical University of South Carolina Institute of PsychiatryCharleston, South Carolina