Understanding the Mechanistic, Neurophysiological, and Antinociceptive Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
The University of Texas Medical Branch, Galveston
Summary
The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The investigator will also investigate changes in the way each participant perceive sensations of pressure and heat. The participant will be asked to reduce the amount of pain medication that they take. Then, the participant will spend several days and nights in the Clinical Research Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the participant will be monitored for withdrawal symptoms and will receive either active (e.g., "real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours each day). At two times over the course of the study (before and after ear stimulation treatment), the participant will complete questionnaires about their pain score and how they are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their brain. The investigator will collect the following information from the participant's medical record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor visits or hospital stays, and results of urine drug tests. Participation in this study will last approximately four days, and the participant will stay in the Clinical Research Center.
Description
Rationale and Aims The current project will build on the previous tAN (transcutaneous auricular neurostimulation) research and clinical studies on chronic pain and opioid withdrawal, ultimately providing a "neural blueprint" of how tAN therapy can mitigate pain and opioid withdrawal symptoms. The investigators will conduct a clinical mechanistic trial of tAN in chronic pain patients tapering from therapeutic opioids. The study will accomplish the following Aim and address the following hypotheses: Aim: Establish the functional MRI (fMRI) neurophysiological signature specifically underlying t…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females between 18 and 65 years of age * Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements * Presence of pain on more than half of the days in the last six months * Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the Prescription Drug Monitoring Program (PDMP) * Willingness to taper opioid dose by at least 10% * Patient or provider requests opioid dose reduction or discontinuation. * Urine Drug Sc…
Interventions
- Devicetranscutaneous Auricular neurostimulation - Active
Active auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved
- Devicetranscutaneous auricular neurostimulation - Sham
Sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX) but will not deliver prolonged stimulation.
Location
- University of Texas Medical BranchGalveston, Texas