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Recruiting NCT06100172

Transcutaneous Auricular Neurostimulation After Lumbar Surgery

Trial Parameters

Condition Pain, Postoperative
Sponsor University of Texas Southwestern Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2024-10-29
Completion 2027-10
Interventions
Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)Sham Control Device

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.

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 th

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