Actively Recruiting
Transcutaneous Auricular Neurostimulation After Lumbar Surgery
Led by University of Texas Southwestern Medical Center · Updated on 2025-12-15
20
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Auricular Neurostimulation After Lumbar Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically cleared to undergo lumbar spine surgery, including spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone
- Aged 18 to 85 years
- Proficient in English
- Able to provide informed consent and function intellectually for study requirements
You will not qualify if you...
- Presence of uncontrolled or clinically significant medical conditions
- History of bleeding disorders or coagulopathy
- History of seizures or epilepsy
- History of neurological diseases or traumatic brain injury
- Use of illegal recreational drugs
- Presence of medical devices such as pacemakers, cochlear prosthesis, or neuro-stimulators
- Use of acupuncture within 4 weeks prior to surgery
- Grossly abnormal external ear anatomy or active ear infection
- Women of childbearing potential not using effective contraception or unwilling to comply with contraception during the study
- Females who are pregnant or breastfeeding
- Any other significant disease or disorder that may risk the participant or affect the trial results or participation, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Alex Valadka, MD
CONTACT
T
Tyfe Oderinde, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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