Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
University of Texas Southwestern Medical Center
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.
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 min…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 br…
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.
Location
- UT Southwestern Medical CenterDallas, Texas