Transcutaneous Auricular Neurostimulation After Lumbar Surgery

NCT ID: NCT06100172

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2027-12-31

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.

Detailed Description

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar spine 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 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.

Conditions

Pain, Postoperative; Opioid Use; Lumbar Spine Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Sham Control Device

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Sham Control Device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alex Valadka

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Valadka, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alex Valadka, MD

Role: CONTACT

alex.valadka@utsouthwestern.edu

214-645-2300

Tyfe Oderinde, MS

Role: CONTACT

Bolutyfe.Oderinde@utsouthwestern.edu

214-648-9905

Facility Contacts

Alex Valadka, MD

Role: primary

alex.valadka@utsouthwestern.edu

214-645-2300

Tyfe Oderinde, MS

Role: backup

Bolutyfe.Oderinde@utsouthwestern.edu

214-648-9905

Other Identifiers

STU-2023-0197

Identifier Type: -

Identifier Source: org_study_id