Recruiting

Transcutaneous Auricular Neurostimulation

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06100172

Conditions

Pain, Postoperative

Opioid Use

Lumbar Spine Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Sham Control Device

Study Details

Brief summary:

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar 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.

Conditions

Pain, Postoperative

Opioid Use

Lumbar Spine Injury

Study ID

NCT06100172

Start date

Oct 29, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without 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 an intellectual level sufficient for study requirements

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 investigator judgment 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, or may influence the result of the trial, or the participant's ability to participate in the trial

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.

Subjects will be randomized to receive the active device on the day of surgery.

Subjects will receive 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

placebo comparator: Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.

Subjects will be randomized to receive the sham device on the day of surgery.

Subjects will receive 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

Interventions

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS). Use of tAN for pain relief is an attractive alternative to pharmacologic and opioid-based approaches because it is safe and effective and presents no addiction liability.

Sham Control Device

This device looks like the active device, but no stimulation will be delivered.

Primary outcome measure

  • Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation [ Time Frame: Baseline, 3 hours post-operation ]
  • Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation [ Time Frame: Baseline, 6 hours post-operation ]
  • Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation [ Time Frame: Baseline, day 2 post-operation ]
  • Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation [ Time Frame: Baseline, day 14 post-operation ]

Central Contacts and Locations

Central contacts

Alex Valadka, MD

214-645-2300alex.valadka@utsouthwestern.edu

Tyfe Oderinde, MS

214-648-9905Bolutyfe.Oderinde@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Alex Valadka, MD

214-645-2300alex.valadka@utsouthwestern.edu

Tyfe Oderinde, MS

214-648-9905Bolutyfe.Oderinde@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Lumbar Surgery
  • Transcutaneous auricular neurostimulation (tAN)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-12-15.