Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Description

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion 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.

Conditions

Pain, Postoperative, Opioid Use, Lumbar Spine Injury

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Study Overview

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Study Details

Study overview

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion 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.

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

Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Condition
Pain, Postoperative
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Medically cleared to undergo a lumbar fusion surgery
  • 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
  • 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Alex Valadka, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2025-07