RecruitingNot ApplicableNCT06100172

Transcutaneous Auricular Neurostimulation After Lumbar Surgery

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

20 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Sham Control Device and a medical device called Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) for people with lumbar spine injury, opioid use, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESparrow 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.

DEVICESham Control Device

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


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06100172


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