Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 29, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Pain, PostoperativeOpioid UseLumbar Spine Injury
Interventions
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.

DEVICE

Sham Control Device

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

Trial Locations (1)

75390

RECRUITING

UT Southwestern Medical Center, Dallas

All Listed Sponsors
lead

University of Texas Southwestern Medical Center

OTHER