Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain (NCT05555485) | Clinical Trial Compass
RecruitingNot Applicable
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
United States60 participantsStarted 2023-05-24
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical opioid withdrawal scale (COWS)
Timeframe: day 1 and day 4
Trial details
NCT IDNCT05555485
SponsorThe University of Texas Medical Branch, Galveston