Transcutaneous Auricular Neurostimulation After Lumbar Surgery

Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Opioid Use; Lumbar Spine Injury
• Intervention / Treatment: Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN); Device: Sham Control Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Valadka, MD; Phone Number: 214-645-2300; Email: alex.valadka@utsouthwestern.edu
• Study Contact Backup: Name: Tyfe Oderinde, MS; Phone Number: 214-648-9905; Email: bolutyfe.oderinde@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Alex Valadka, MD; Phone Number: 214-645-2300; Email: alex.valadka@utsouthwestern.edu
      • Contact: Tyfe Oderinde, MS; Phone Number: 214-648-9905; Email: bolutyfe.oderinde@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: 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.
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	Device: Sham Control Device; This device looks like the active device, but no stimulation will be delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery	During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.	3 hours post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery	During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.	6 hours post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery	During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.	Day 2 post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery	During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.	Day 7 post-surgery
Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery	During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction.	Day 14 post-surgery
Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op)	CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.	Baseline and at Day 1 (intra-op)
Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op	CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.	Baseline and at 6 hours post-op
Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op	CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay.	Baseline and at Day 2 post-op
Mean percent change in TNF-alpha levels from baseline at 6 hours post-op	TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups.	Baseline and at 6 hours post-op
Surgery time (incision to closure)	A comparison of the surgery times from incision to closure will be compared between the 2 groups to determine if the tAN affects the surgery time. The times will be recorded for each case, and then compared between the two groups. Surgery time - calculated as time from first incision to closure.	Day 1- during surgery [Surgery start (incision) to closure of surgical site]
Mean percent change in Tumor Necrosis factor (TNF)-alpha levels from baseline at Day 1 (intra-op)	TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups.	Baseline and at Day 1 (intra-op)
Estimated mean total blood loss	During surgery, blood will be collected using cell saver technology which allows for accurate recording of total blood loss. The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparison is based on end volume recorded at incision closure.	Day 1- During surgery [Surgery start (incision) to closure]

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Alex Valadka, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lumbar Surgery; Transcutaneous auricular neurostimulation (tAN)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Back Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Spinal Injuries
• Other Study ID Numbers: STU-2023-0197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No