Transcutaneous Auricular Neurostimulation After Lumbar Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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
Qualifiers
Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone.
18-85 years of age
English Proficiency
Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements
Disqualifiers
Current evidence of an uncontrolled and/or clinically significant medical condition
History of bleeding disorders or coagulopathy
History of seizures or epilepsy
History of neurological diseases or traumatic brain injury
Trial design
Treatments tested in this trial
- Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
- Sham Control Device
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov