RECRUITING

Transcutaneous Auricular Neurostimulation After Lumbar Surgery

Conditions

Pain, Postoperative Opioid Use Lumbar Spine Injury Lumbar Surgery Transcutaneous auricular neurostimulation (tAN)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-29

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06100172

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.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Alex Valadka, MD

CONTACT

214-645-2300

alex.valadka@utsouthwestern.edu

Tyfe Oderinde, MS

CONTACT

214-648-9905

Bolutyfe.Oderinde@utsouthwestern.edu

Principal Investigator

Alex Valadka, MD

PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Alex Valadka, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-10-29

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Lumbar Surgery
Transcutaneous auricular neurostimulation (tAN)

Additional Relevant MeSH Terms

Pain, Postoperative
Opioid Use
Lumbar Spine Injury