Clinical Evidence

This blinded, prospective, randomized control trial is designed to investigate the impact of transcutaneous auricular neurostimulation (tAN) on blood loss during surgery in patients undergoing functional endoscopic sinus surgery (FESS). Functional endoscopic sinus surgery is an important procedure for controlling a variety of sinus disease. Given the proximity to the brain and vascularity of tissues, good visualization is paramount. Intraoperative bleeding may obscure the view of the surgeon. In this study, the investigators will use a tAN to determine its effects on decreased perioperative blood loss to determine if it could lead to better surgical conditions during the surgery.

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.

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.

The purpose of this series of clinical trials is to test a novel closed-loop cognitive augmentation system to enhance attention, task performance under stress, and resilience to cybersickness. The system will automatically apply transcutaneous auricular neurostimulation (tAN) at optimal times according to cognitive state metrics derived from multimodal biosensors. This system will be validated incrementally through several experiments to refine a prototype neural interface.

This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. Two wearable sensors will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels. The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

This study is designed as a randomized, double-blind, sham-controlled trial performed in a healthy human model of acute stress. The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor. This study utilizes the Sparrow Hawk to deliver tAN with a compact, single use, ergonomic form factor designed for military applications.

The IMBUE RETAIN trial is a 2-year pilot randomized clinical trial designed to achieve milestones determining the feasibility, tolerability, and device adherence of administering tAN therapy to a population with co-occurring PTSD/OUD population in the context of buprenorphine therapy initiation and stabilization. The objective of this study is to establish the preliminary efficacy of tAN-facilitated buprenorphine treatment retention at 3-months as well as assess the effect of tAN on PTSD symptom severity and opioid withdrawal symptoms. This study will power a larger pivotal trial in the same population.

A first-of-its-kind, randomized,  controlled trial with a double-blind study to really measure the efficacy of  tAN to alleviate acute opioid withdrawal symptoms, as well as longer term opioid  withdrawal symptoms over 2-5 days of detox. The study objective is to  measure a clinically significant reduction in opioid withdrawal symptoms, as measured by the Clinical  Opioid Withdrawal Scale (COWS), after 60 minutes of tAN  therapy. This was designed to show the safety and efficacy of the  stimulation and also the durability, day after day. This  study provided evidence to support the initial FDA clearance of the Sparrow  Therapy System, Spark’s first-generation device.

RESTORE is a prospective,randomized, controlled, multi-center, clinical trial aimed at studying the effectsof tAN to reduce rates of relapse, increase treatment retention, reduce opioidwithdrawal symptoms and opioid cravings. Participants are randomized into a 7-dayacute detox phase where they are randomized to receive active or sham tAN incombination with Lofexidine (Lucemyra) or a placebo.  Participants may then randomize into a 3-monthtreatment phase to receive either active tAN plus Naltrexone (Vivitrol) orNaltrexone alone. The study objective is to determine the synergistic effectsof tAN therapy with non-opioid based medications to reduce rates of relapse.