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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv8
  2. Minor Site contact updatedv7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Minor Site contact updated
    • Collaborators: 1 to 2
    v5
  5. Notable Start date: Mar 3, 2023 to May 24, 2023
    • Primary completion date: Oct 30, 2027 to Jul 21, 2027
    • Study completion date: Oct 30, 2028 to Sep 30, 2027
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2022 to Mar 3, 2023
    • Site details revised
    v3
  2. Notable Start date: Oct 1, 2022 to Dec 15, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05555485
Lead Sponsor The University of Texas Medical Branch, Galveston
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Medical University of South Carolina
Conditions
(from sponsor)
Opioid Withdrawal, Analgesia
Related terms Agnosia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov