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NCT05555485 · ClinicalTrials.gov registry record · NA
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
A NA study of Analgesia and Opioid Withdrawal, sponsored by The University of Texas Medical Branch, Galveston.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05555485: Recruiting NA study of Analgesia and Opioid Withdrawal, sponsored by The University of Texas Medical Branch, Galveston.
NCT05555485 is a NA study of Analgesia and Opioid Withdrawal that is actively recruiting participants, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 60 participants, below the 90-participant average among 19 other Analgesia trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05555485, a NA study of Analgesia and Opioid Withdrawal, is actively recruiting participants, sponsored by The University of Texas Medical Branch, Galveston.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Examination and scoring of symptoms of opioid withdrawal. score range is 1-36 with 1-2 mild, 3-24 moderate, and 25-36 severe withdrawal symptoms measured pre-treatment (day 1) and post-treatment (day4
Conditions Studied
Interventions
- DEVICE transcutaneous Auricular neurostimulation - Active
- DEVICE transcutaneous auricular neurostimulation - Sham
Study Locations (1)
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-24 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
What NCT05555485 shows while recruiting
NCT05555485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 90-participant average among 19 other Analgesia trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Analgesia appearing as the primary indexed condition, and to 2 interventions - of which transcutaneous Auricular neurostimulation - Active is the first listed.
NCT05555485 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05555485 about?
NCT05555485 is a clinical study titled "Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain". 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 a...
What is the current status of trial NCT05555485?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-05-24. Estimated completion is 2027-09-30.
What conditions does trial NCT05555485 study?
This clinical trial studies the following conditions: Analgesia, Opioid Withdrawal.
What interventions are being tested in trial NCT05555485?
The interventions under investigation include: transcutaneous Auricular neurostimulation - Active (DEVICE), transcutaneous auricular neurostimulation - Sham (DEVICE).
Who is sponsoring clinical trial NCT05555485?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05555485 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05555485's enrollment target sits among peer trials
60 14th of 19 higher than 5 of 19 other Analgesia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Analgesia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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