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Auricular Neurostimulation for Chronic Pain

N/A
Recruiting
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females between 18 and 65 years of age
Patient or provider requests opioid dose reduction or discontinuation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day4
Awards & highlights

Study Summary

This trial is testing a new brain stimulation device to see if it can help with pain relief and withdrawal symptoms. The study will last 4 days and involve questionnaires, sensory testing, and MRI scans.

Who is the study for?
This trial is for adults aged 18-65 with chronic pain, who are on opioid medication and willing to reduce their dose by at least 10%. They must not have a history of seizures, neurological diseases, or ear problems. Participants should test negative for illicit drugs and nonprescribed opioids but positive for prescribed ones. Pregnant women or those at risk of pregnancy without proper contraception are excluded.Check my eligibility
What is being tested?
The study tests transcutaneous auricular neurostimulation (TAN), a device worn on the ear believed to alleviate pain and opioid withdrawal symptoms by stimulating nerves. Participants will receive either real TAN or sham (fake) treatment while reducing opioid use over four days in a clinical setting.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the ear, headache, dizziness, or skin irritation from the device. Since participants will be tapering off opioids, they might also experience withdrawal symptoms which will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I want to lower or stop my opioid medication.
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I am willing to reduce my opioid dose by at least 10%.
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My drug test shows I'm taking my prescribed opioid.
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I can show my medication is prescribed to me.
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I have experienced pain on most days in the past six months.
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I want to lower or stop my opioid medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical opioid withdrawal scale (COWS)
Secondary outcome measures
Pain
Patient Health Questionnaire (PHQ9)
Patient reported outcome measurement anxiety (PROMIS-A): questionnaire
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: tAN stimulation - activeActive Control1 Intervention
Active or sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved
Group II: tAN stimulation - shamPlacebo Group1 Intervention
Active or sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX). The tAN devices are portable, wearable systems with two channels of stimulation (auricular vagus and auricular trigeminal). Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set at 250 µs for all participants. The stimulation intensities (mA) will be set at 1.0 and 1.4 (for Regions 1 and 2, respectively) based on values observed in previous clinical studies. If the participant states that the stimulation intensity is discomforting or unperceivable, the study personnel will gradually decrease/increase the intensity until a comfortable stimulation intensity is achieved.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
244 Previous Clinical Trials
56,692 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,345 Previous Clinical Trials
650,693 Total Patients Enrolled

Media Library

Transcutaneous Auricular Neurostimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05555485 — N/A
Opioid Withdrawal Syndrome Research Study Groups: tAN stimulation - active, tAN stimulation - sham
Opioid Withdrawal Syndrome Clinical Trial 2023: Transcutaneous Auricular Neurostimulation Highlights & Side Effects. Trial Name: NCT05555485 — N/A
Transcutaneous Auricular Neurostimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555485 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to enroll in this medical trial?

"This clinical trial requires 60 adults, ages 18-65, suffering from analgesia to meet the following criteria: Willingly decrease opioid dose by 10%, Requesting a lowering or cessation of opioids., Urine Drug Screen (UDS) must be positive for their prescribed opioid, Urine Drug Test must be negative for illicit drugs, benzodiazepines and nonprescribed opioids. Additionally, nicotine patches/gum are required over smoking/vaping in UTMB facilities. Patients must also consent intelligently and have experienced pain on more than half of days in past 6 months; as well as demonstrate proof of prescription medication either with bottle bearing"

Answered by AI

Are there still vacancies available in this medical trial?

"This specific trial is not presently recruiting volunteers, as indicated on clinicaltrials.gov. Initially posted in December 15th 2022, the last edit was made November 14th of that same year; yet there are 507 alternate trials actively looking for participants at this time."

Answered by AI

Are individuals beyond the age of 45 years eligible to join this experiment?

"This trial is only open to individuals aged 18-65. However, there are an additional 44 trials for minors and 439 trials specifically catering towards senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Texas Medical Branch
Recent research and studies
clinicaltrials.govStudy
Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
Wilkes, Denise 2023. "Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05555485.
~40 spots leftby Jul 2027
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