Transcutaneous Auricular Neurostimulation After Lumbar Surgery

NCT06100172 | Recruiting FDA Device

• 1 other identifier: STU-2023-0197
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Lumbar Surgery; Transcutaneous auricular neurostimulation (tAN)

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation

  Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  Baseline, 3 hours post-operation

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation

  Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  Baseline, 6 hours post-operation

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation

  Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  Baseline, day 2 post-operation

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation

  Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0="no pain" to 10="severe pain"

  Baseline, day 14 post-operation

Secondary Outcomes (12)

• Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery

  3 hours post-surgery

• Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery

  6 hours post-surgery

• Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery

  Day 2 post-surgery

• Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery

  Day 7 post-surgery

• Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery

  Day 14 post-surgery

Study Arms (2)

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

ACTIVE COMPARATOR

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

Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

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

PLACEBO COMPARATOR

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

Device: Sham Control Device

Interventions

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) DEVICE

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.

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

Sham Control Device DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone.
• years of age
• English Proficiency
• Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

You may not qualify if:

• Current evidence of an uncontrolled and/or clinically significant medical condition
• History of bleeding disorders or coagulopathy
• History of seizures or epilepsy
• History of neurological diseases or traumatic brain injury
• Use of illegal recreational drugs
• Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators
• Use of acupuncture within 4 weeks of surgery
• Grossly abnormal external ear anatomy or active ear infection
• Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study
• Females who are pregnant or lactating
• 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

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Spinal Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Back Injuries; Wounds and Injuries

Study Officials

• Alex Valadka, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Valadka, MD

CONTACT

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

Tyfe Oderinde, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: On the day of surgery, subjects will be randomized 1:1 to either the active stimulation group or the sham group. In the sham group, the device looks like the active device, but it will not deliver any electrical stimulation to the vagus or trigeminal nerves. Both groups will receive the SOC for post-operative pain management for lumbar surgery patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, double blind, sham controlled.

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 25, 2023
• Study Start: October 29, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)