Clinical Trials

The overarching goal of this single-center, open-label, pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tAN) in patients admitted to the intensive care unit (ICU) with TBI and to determine the effect of tAN on serum markers of inflammation. Exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.

The purpose of this study is to demonstrate whether transcutaneous auricular neurostimulation (tAN®) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion surgery. This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which participants undergoing lumbar fusion surgery will receive either active or sham tAN before, during, and in the two days following surgery. The objective of the trial is to determine whether tAN can reduce pain, post operative consumption of opioids, and surgical blood loss.

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 UTMB, is the third of three trials funded under this HEAL initiative mechanism. In this randomized controlled trial, participants dependent on chronic pain medications will receive either active or sham tAN during medication weaning over a four-day inpatient stay. Participants will be monitored for withdrawal and will undergo magnetic resonance imaging. The primary objective of the trial is to measure the reduction in opioid withdrawal symptoms using active vs. sham tAN.

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.