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

NCT05555485 | Recruiting DMC FDA Device

• 2 other identifiers: 22-01871RM1NS128787-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Withdrawal; Analgesia

Outcome Measures

Primary Outcomes (1)

• Clinical opioid withdrawal scale (COWS)

  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

  day 1 and day 4

Secondary Outcomes (4)

• Pain, enjoyment, and general activity (PEG3)

  day 1 and day 4

• Patient Health Questionnaire (PHQ9)

  day 1 and day 4

• Patient reported outcome measurement anxiety (PROMIS-A): questionnaire

  day 1 and day4

• Patient reported outcome measurement depression (PROMIS-D): questionnaire

  day 1 and day4

Study Arms (2)

tAN stimulation - sham

SHAM COMPARATOR

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.

Device: transcutaneous auricular neurostimulation - Sham

tAN stimulation - active

ACTIVE COMPARATOR

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

Device: transcutaneous Auricular neurostimulation - Active

Interventions

transcutaneous Auricular neurostimulation - Active DEVICE

Active 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

Also known as: the Sparrow

tAN stimulation - active

transcutaneous auricular neurostimulation - Sham DEVICE

Sham auricular stimulation will be conducted using the FDA-cleared tAN device (Sparrow®) manufactured by Spark Biomedical (Dallas, TX) but will not deliver prolonged stimulation.

tAN stimulation - sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 past 10 years.
• Current suicidal ideation with specific plan or intent
• Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
• Females who are pregnant or lactating
• Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Related Publications (1)

• Pierson CJ, Khodaparast N, McWade MA, Kuo YF, Houghton DC, Rodriguez SL, Korschgen VL, Cunningham KA, Wilkes DM. The protocol for a randomized, sham-controlled trial of transcutaneous auricular neurostimulation for chronic pain and opioid withdrawal symptoms during a 4-day opioid taper for adults in the United States. Trials. 2025 Oct 16;26(1):421. doi: 10.1186/s13063-025-09171-4.

  PMID: 41102821 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placement of either active or sham tAN device will be done by dedicated and unblinded study personnel. These study personnel will administer active tAN or sham tAN stimulation and have no additional involvement with participants or data collection. No other study staff members at UTMB who interact with participants or collect data will know which type of stimulation the participants received. Participants will additionally remain unaware (e.g., masked) of which type of tAN they are receiving until after study completion. 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will be randomized to one of two arms (active tAN vs. sham tAN) in a 1:1 fashion such that each arm will have 20 participants with complete data. A block randomization procedure will be utilized to ensure that equal numbers of participants are assigned to each of the two conditions.

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 27, 2022
• Study Start: May 24, 2023
• Primary Completion (Estimated): July 21, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)