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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 24, 2023

Primary Completion Date

July 21, 2027

Study Completion Date

September 30, 2027

Conditions
Opioid WithdrawalAnalgesia
Interventions
DEVICE

transcutaneous Auricular neurostimulation - Active

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

DEVICE

transcutaneous auricular neurostimulation - Sham

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.

Trial Locations (1)

77555

RECRUITING

University of Texas Medical Branch, Galveston

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Medical University of South Carolina

OTHER

lead

The University of Texas Medical Branch, Galveston

OTHER