Transcutaneous Auricular Neurostimulation After Lumbar Surgery

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06100172
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) — 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.
  • Sham Control Device — DEVICE
    This device looks like the active device, but no stimulation will be delivered.

Study Details

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.

Key Dates

Start date
Oct 29, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.
    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
  • Placebo Comparator: Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.
    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

Primary Outcome Measure

Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation [ Time Frame: Baseline, 3 hours post-operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Alex Valadka, MD
[email protected]
214-645-2300
Tyfe Oderinde, MS
[email protected]
214-648-9905

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