Clinical Trials

The NIH HEAL initiative funded the tANdem trial, made up of 3 clinical trials, to investigate the mechanism of tAN therapy as a non-pharmacologic modality to treat chronic pain. This randomized, double-blind, sham-controlled trial, led by Medical University of South Carolina, is the second of three trials funded under this HEAL initiative mechanism. In this single-visit, randomized, double-blind, sham-controlled trial, a novel concurrent transcutaneous auricular neurostimulation (tAN) paradigm during functional magnetic resonance imaging (fMRI) is used 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). The primary objective is to measure brain imaging signal changes during neurostimulation relative to no neurostimulation.

The NIH HEAL initiative funded the tANdem trial, made up of 3 clinical trials, to investigate the mechanism of tAN therapy as a non-pharmacologic modality to treat chronic pain. This randomized, double-blind, sham-controlled trial, led by Medical University of South Carolina, is the first of three trials funded under this HEAL initiative mechanism. Participants are delivered an opioid receptor blockade (naloxone) to determine whether the anti-pain effects of transcutaneous auricular neurostimulation (tAN) intervention are mediated through a release of the body’s natural opioids. Effects of stimulation at four locations will be measured (auricular vagus, auricular trigeminal, combination, or sham) while varying the type of intravenous (IV) infusion (either naloxone or saline) a participant is administered to determine whether the anti-pain effects are mitigated by pharmacological opioid receptor blockade. Participants receive functional magnetic resonance imaging. The primary objective is the comparison of the change in thermal pain thresholds from baseline in each condition.

This study is designed as a double-blind, randomized, sham-controlled, multi-center trial to determine the safety and efficacy of transcutaneous auricular neurostimulation (tAN) as an adjunct treatment for neonatal opioid withdrawal symptoms (NOWS). Neonates receiving oral morphine for NOWS symptoms were randomized to receive active or sham tAN plus standard of care during their stay in the neonatal intensive care unit. The objective of the trial was to determine if tAN can reduce length of treatment with oral morphine by alleviating opioid withdrawal symptoms.

This is a prospective, double-blinded, randomized controlled study to evaluate transcutaneous auricular neurostimulation (tAN), a non-invasive, non-sedating, non-pharmacologic, commercially-available neuromodulation technology to prevent and reduce motion sickness (MS) and spatial disorientation (SD). Participants will receive active or sham tAN prior to exposure to a flight simulation designed to induce motion sickness and spatial disorientation. Following exposure, cognitive performance tasks, neurologic examination and post-stimuli assessments of motion sickness and spatial disorientation will be collected. The primary objective is to determine the feasibility of tAN to reduce spatial disorientation, which is a leading cause of military deaths.