๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
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What it tests
- Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
- Sham Control Device
UT Southwestern Medical Center
Dallas, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.