Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Last updated: August 30, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Drug Use

Treatment

Sham Control Device

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Clinical Study ID

NCT06100172
STU-2023-0197
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Medically cleared to undergo a lumbar spine surgery, either spinal fusion with orwithout multilevel laminectomies, or lumbar multilevel laminectomies alone.

  2. 18-85 years of age

  3. English Proficiency

  4. Participants must be able to provide informed consent and function at anintellectual level sufficient for study requirements

Exclusion

Exclusion Criteria:

  1. Current evidence of an uncontrolled and/or clinically significant medical condition

  2. History of bleeding disorders or coagulopathy

  3. History of seizures or epilepsy

  4. History of neurological diseases or traumatic brain injury

  5. Use of illegal recreational drugs

  6. Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators

  7. Use of acupuncture within 4 weeks of surgery

  8. Grossly abnormal external ear anatomy or active ear infection

  9. Women of childbearing potential, not using effective contraception per investigatorjudgment or not willing to comply with contraception for the duration of the study

  10. Females who are pregnant or lactating

  11. 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, ormay influence the result of the trial, or the participant's ability to participatein the trial

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Sham Control Device
Phase:
Study Start date:
October 29, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar fusion surgery will be randomized 1:1 into one of two treatment groups:

  1. Group 1 (n=10): Active tAN + standard care

  2. Group 2 (n=10): Sham tAN + standard care

Stimulation:

Participants undergoing lumbar fusion surgery will be randomized to receive either active or sham tAN treatment according to the following time points:

  • Pre-operative: 30 minutes in the hour prior to surgery

  • Intra-operative: 30 minutes before the end of surgery

  • Post-operative: 30 minutes at 3 and 6 hours after surgery

  • Inpatient: Four 30-minute sessions on Day 2

Blood Draws

Participants will have blood samples collected at the following time points:

  • Day 1 (Day of Surgery)

  • Day 2 (Day 1 post-surgical)

Follow up Visits Participants will have study follow up visits on Days 7 and Day 14. These visits can either be conducted either via a secure telehealth video visit, or in person visit.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

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