About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- transcutaneous Auricular neurostimulation - Active
- transcutaneous auricular neurostimulation - Sham
Treatment groups
Sponsors and collaborators
The University of Texas Medical Branch, Galveston
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Medical University of South Carolina
Collaborator