An interventional study of Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) and Sham Control Device in Pain, Postoperative, Opioid Use and Lumbar Spine Injury, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
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:
Stimulation:
Participants undergoing lumbar surgery will be randomized to receive either active or sham tAN treatment according to the following time points:
Blood Draws
Participants will have blood samples collected at the following time points:
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 20 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
This device looks like the active device, but no stimulation will be delivered.
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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: Baseline, day 14 post-operation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1- during surgery [Surgery start (incision) to closure of surgical site]
Estimated mean total blood loss
During surgery, blood will be collected using cell saver technology which allows for accurate recording of total blood loss. The volume of blood loss will be recorded for each case, and then the 2 groups will be compared. Comparison is based on end volume recorded at incision closure.
Time frame: Day 1- During surgery [Surgery start (incision) to closure]
Plan to share: No
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