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Transcutaneous Auricular Neurostimulation After Lumbar Surgery
Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery
Who can join
Ages 18 to 85 · All sexes
Full 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 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
About the study
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.
What is being tested
- Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) (device)
- Sham Control Device (device)
Sponsor: University of Texas Southwestern Medical Center · Participants: 20 · Started: Oct 29, 2024
Contact the study team
- Alex Valadka, MD · Phone: 214-645-2300
- Tyfe Oderinde, MS · Phone: 214-648-9905
Official record on ClinicalTrials.gov — NCT06100172
Locations in the U.S.
| Texas | UT Southwestern Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.