Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Sep 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a device that is worn on the ear, called a transcutaneous auricular neurostimulation device, to see how it can help manage chronic pain and reduce symptoms of opioid withdrawal. The device is thought to stimulate nerves near the ear, which may help change how pain is felt in the brain. Participants will be asked to decrease their pain medication by at least 10% and will stay at the University of Texas Medical Branch in Galveston for about four days. During their stay, they will either receive real or fake stimulation for two days, while also completing questionnaires about their pain and undergoing brain scans.

To be eligible for this study, participants should be between 18 and 65 years old and have experienced pain on more than half of the days in the last six months. They need to show proof of their prescribed pain medication and be willing to cut back on their opioid use. Certain health conditions, such as ongoing cancer treatment or a history of seizures, may disqualify individuals from participating. Throughout the trial, participants will be closely monitored for their pain levels and any withdrawal symptoms, helping to provide valuable information about this new approach to pain management.

Gender

ALL

Eligibility criteria

• 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 Screen (UDS) must be positive for their prescribed opioid
• • Urine Drug Test must be negative for illicit drugs, benzodiazepines, and nonprescribed opioids
• • Must agree to use nicotine patches and/or gum instead of smoking or vaping in the UTMB facilities
• Exclusion Criteria:
• • 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
• • Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
• • Currently receiving a prescription benzodiazepine medication
• • Current prescription opioid dose \>50 MME/day
• • Current abuse of illicit drugs or alcohol (nicotine use is acceptable).
• • Surgery within the previous month
• • Report of suicide attempt or psychiatric hospitalization in the past 10 years.
• • Current suicidal ideation with specific plan or intent
• • Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
• • Females who are pregnant or lactating
• • Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial