Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Group 1 (n=10): Active tAN + standard care 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.

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

Conditions
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Pain, Postoperative, Opioid Use, Lumbar Spine Injury

Intervention / Treatment
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* Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
* Device: Sham Control Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically cleared to undergo a lumbar fusion surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blind, sham controlled.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.<br>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 | Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)<br>* 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 stimulation (TNS). Use of tAN for pain relief is an attractive alternative to pharmacologic and opioid-based approaches because it is safe and effective and presents no addiction liability.<br>|
| Placebo Comparator: Sham tAN + standard of care (SOC) for post-operative pain management for lumbar fusion patients.<br>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 | Device: Sham Control Device<br>* This device looks like the active device, but no stimulation will be delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation | Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0=no pain to 10=severe pain | Baseline, 3 hours post-operation | 
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation | Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0=no pain to 10=severe pain | Baseline, 6 hours post-operation | 
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation | Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0=no pain to 10=severe pain | Baseline, day 2 post-operation | 
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation | Patients will be asked to report their level of pain using the Visual Analog Scale. Possible scores for VAS pain scale ranges from 0-10 where 0=no pain to 10=severe pain | Baseline, day 14 post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery | During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction. | 3 hours post-surgery | 
| Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery | During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction. | 6 hours post-surgery | 
| Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery | During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction. | Day 2 post-surgery | 
| Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery | During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction. | Day 7 post-surgery | 
| Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery | During the in-patient hospital stay, the dose and frequency of post -operative opioid use will recorded for both the placebo and active groups. The opioid usage between the 2 groups will be compared to determine if the active group required less opioid medications for pain reduction. | Day 14 post-surgery | 
| Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op) | CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay. | Baseline and at Day 1 (intra-op) | 
| Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op | CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay. | Baseline and at 6 hours post-op | 
| Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op | CRP blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. Plasma levels of C-reactive protein will be determined by the immunoprecipitation method using an in vitro diagnostic assay. | Baseline and at Day 2 post-op | 
| Mean percent change in TNF-alpha levels from baseline at Day 1 (intra-op) | TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. | Baseline and at Day 1 (intra-op) | 
| Mean percent change in TNF-alpha levels from baseline at 6 hours post-op | TNF-alpha blood samples collected will be used to measure the amount of inflammation in the body at the time points stated, and changes will be recorded and compared between the 2 groups. | Baseline and at 6 hours post-op | 
| Surgery time (incision to closure) | A comparison of the surgery times from incision to closure will be compared between the 2 groups to determine if the tAN affects the surgery time. The times will be recorded for each case, and then compared between the two groups. Surgery time - calculated as time from first incision to closure. | Day 1- during surgery [Surgery start (incision) to closure of surgical site] | 
| Estimated mean total blood loss | The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparision is based on end volume recorded at incision closure. | Day 1- During surgery [Surgery start (incision) to closure] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Fusion, Transcutaneous auricular neurostimulation (tAN)