Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

The University of Texas System (UT)

Status: Enrolling

Conditions: Lumbar Spine Injury; Pain, Postoperative; Opioid Use

Treatments: Device: Sham Control Device; Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Study type: Interventional

Funder types: Other

Identifiers

NCT06100172

STU-2023-0197

Details and patient eligibility

About

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.

Full description

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar fusion surgery will be randomized 1:1 into one of two treatment groups:

1. Group 1 (n=10): Active tAN + standard care
2. Group 2 (n=10): Sham tAN + standard care

Stimulation:

Participants undergoing lumbar fusion surgery will be randomized to receive either active or sham tAN treatment according to the following time points:

• Pre-operative: 30 minutes in the hour prior to surgery
• Intra-operative: 30 minutes before the end of surgery
• Post-operative: 30 minutes at 3 and 6 hours after surgery
• Inpatient: Four 30-minute sessions on Day 2

Blood Draws

Participants will have blood samples collected at the following time points:

• Day 1 (Day of Surgery)
• Day 2 (Day 1 post-surgical)

Follow up Visits Participants will have study follow up visits on Days 7 and Day 14. These visits can either be conducted either via a secure telehealth video visit, or in person visit.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.

Active Comparator group

Description:

Subjects will be randomized to receive the active device on the day of surgery. Subjects will receive treatment according to the following time points: * Pre-operative: 30 minutes in the hour prior to surgery * Intra-operative: 30 minutes before the end of surgery * Post-operative: 30 minutes at 3 and 6 hours after surgery * Inpatient: Four 30-minute sessions on Day 2

Treatment:

Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.

Placebo Comparator group

Description:

Subjects will be randomized to receive the sham device on the day of surgery. Subjects will receive treatment according to the following time points: * Pre-operative: 30 minutes in the hour prior to surgery * Intra-operative: 30 minutes before the end of surgery * Post-operative: 30 minutes at 3 and 6 hours after surgery * Inpatient: Four 30-minute sessions on Day 2

Treatment:

Device: Sham Control Device