Transcutaneous Auricular Neurostimulation After Lumbar Surgery

Official title

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

Overview

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.

Detailed description

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar spine 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 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.

Interventions

• Device Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
  This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve s
• Device Sham Control Device
  This device looks like the active device, but no stimulation will be delivered.

Primary outcome measures

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation [Time frame: Baseline, 3 hours post-operation]
• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation [Time frame: Baseline, 6 hours post-operation]
• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation [Time frame: Baseline, day 2 post-operation]
• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation [Time frame: Baseline, day 14 post-operation]

Secondary outcome measures (12)

• Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery [Time frame: 3 hours post-surgery]
• Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery [Time frame: 6 hours post-surgery]
• Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery [Time frame: Day 2 post-surgery]
• Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery [Time frame: Day 7 post-surgery]
• Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery [Time frame: Day 14 post-surgery]
• Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op) [Time frame: Baseline and at Day 1 (intra-op)]
• Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op [Time frame: Baseline and at 6 hours post-op]
• Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op [Time frame: Baseline and at Day 2 post-op]
• Mean percent change in Tumor Necrosis factor (TNF)-alpha levels from baseline at Day 1 (intra-op) [Time frame: Baseline and at Day 1 (intra-op)]
• Mean percent change in TNF-alpha levels from baseline at 6 hours post-op [Time frame: Baseline and at 6 hours post-op]
• Surgery time (incision to closure) [Time frame: Day 1- during surgery [Surgery start (incision) to closure of surgical site]]
• Estimated mean total blood loss [Time frame: Day 1- During surgery [Surgery start (incision) to closure]]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• Use of illegal recreational drugs
• Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators
• Use of acupuncture within 4 weeks of surgery
• Grossly abnormal external ear anatomy or active ear infection
• Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study
• Females who are pregnant or lactating
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• UT Southwestern Medical Center — Dallas

Identifiers

NCT: NCT06100172 · STU-2023-0197

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗