Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05555485

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

Led by The University of Texas Medical Branch, Galveston · Updated on 2025-06-10

60

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Medical Branch, Galveston

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females between 18 and 65 years of age
  • Ability to provide informed consent and function intellectually for study requirements
  • Pain present on more than half of the days in the last six months
  • Proof of prescribed opioid medication (prescription bottle or Prescription Drug Monitoring Program record)
  • Willingness to taper opioid dose by at least 10%
  • Patient or provider requests opioid dose reduction or discontinuation
  • Urine Drug Screen positive for prescribed opioid
  • Urine Drug Test negative for illicit drugs, benzodiazepines, and nonprescribed opioids
  • Agreement to use nicotine patches or gum instead of smoking or vaping in UTMB facilities
Not Eligible

You will not qualify if you...

  • Currently receiving treatment for cancer
  • History of epileptic seizures
  • History of neurological diseases or traumatic brain injury
  • Abnormal ear anatomy or current ear infection
  • Presence of devices like pacemakers, cochlear prosthesis, or neurostimulators
  • Currently prescribed benzodiazepine medication
  • Current prescription opioid dose greater than 50 MME/day
  • Current abuse of illicit drugs or alcohol (nicotine use is acceptable)
  • Surgery within the previous month
  • 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 or unwilling to comply during the study
  • Pregnant or lactating females
  • Any other significant disease or disorder that may put the participant at risk or affect study results

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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