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.
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)
Currently receiving treatment for cancer
Participant has a history of epileptic seizures
Participant has a history of neurological diseases or traumatic brain injury
Participant has abnormal ear anatomy or current ear infection present
Parallel
transcutaneous Auricular neurostimulation - Active
DeviceActive 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
transcutaneous auricular neurostimulation - Sham
DeviceSham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX) but will not deliver prolonged stimulation.
Clinical opioid withdrawal scale (COWS)
Examination and scoring of symptoms of opioid withdrawal. score range is 1-36 with 1-2 mild, 3-24 moderate, and 25-36 severe withdrawal symptoms measured pre-treatment (day 1) and post-treatment (day4
Pain, enjoyment, and general activity (PEG3)
changes from pre to post questionnaires. The scale is 0-30 with the lowest score is the best and higher scores are worse.
Patient Health Questionnaire (PHQ9)
This measures depression. The scale is 0-20 with less than 4 does not need treatment, 5-13 clinical judgement decides treatment, and greater than 14 needs treatment
Patient reported outcome measurement anxiety (PROMIS-A): questionnaire
This questionnaire measures anxiety with a scale of 36-82. A t-score of 55-59.9 is mild, 60-69.9 is moderate, and greater than 70 is severe
Patient reported outcome measurement depression (PROMIS-D): questionnaire
This questionnaire measures depression with a scale of 8-40. The higher the score the more severe is the depression.
Click on the lead sponsor to view all of their trials.
The University of Texas Medical Branch, Galveston
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Medical University of South Carolina
Collaborator
