Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

NCT07218133 | Recruiting FDA Device

• 1 other identifier: 202407057SpineVNS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Conditions

Spinal Fusion; Hyperglycemia; Postoperative Pain Management; Postoperative Care; Spine Disease; Neurologic Deficits; Neurological Disorder; Inflammation; Spine Condition; Spinal (Fusion) Surgery; Cytokine Levels; Spine Fusion

Keywords

spinal fusion; postoperative pain; glycemic control; inflammation; vagal nerve stimulation; postoperative complications; cytokine; spine surgery

Outcome Measures

Primary Outcomes (1)

• Inflammatory cytokine levels

  The levels of 4 different inflammatory cytokines will be measured: interleukin-6 (IL-6), IL-1, IL-10, and tumor necrosis factor alpha (TNF-a) (all measured in pg/ml). Blood for these tests will be drawn preoperatively, postoperatively, on postop day 3, and postop day 6 (or time of discharge).

  5-10 days (depending on hospital admission length)

Secondary Outcomes (13)

• Pain scores

  5-10 days (depending on hospital admission length)

• blood glucose levels

  5-10 days (depending on hospital admission length)

• Postoperative adverse events/complications

  5-10 days (depending on hospital admission length)

• Secondary markers of inflammation

  5-10 days (depending on hospital admission length)

• Post-hospitalization disposition

  5-10 days (depending on hospital admission length)

Study Arms (2)

Auricular vagal nerve stimulation

EXPERIMENTAL

Participants will receive vagal nerve stimulation twice on the day of surgery (once preoperatively) and twice daily postoperatively for duration of hospitalization. All patients will be fitted with the device via adhesive contacts to the left ear. Stimulation will occur for 20 minutes per session. The intervention will provide stimulation according to the following parameters: frequency 20 Hz, pulse width 250 µm, and fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation

Device: Auricular vagus nerve stimulation

Sham vagal nerve stimulation

SHAM COMPARATOR

Participants will have an auricular vagal nerve stimulator device applied in the same manner as the experimental arm, but they will not receive the actual stimulation.

Device: Sham Auricular Vagus nerve Stimulation

Interventions

Auricular vagus nerve stimulation DEVICE

Transcutaneous auricular vagal nerve stimulation

Auricular vagal nerve stimulation

Sham Auricular Vagus nerve Stimulation DEVICE

Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Sham vagal nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Long-segment spinal fusions (defined as constructs spanning at least L2-pelvis for thoracolumbar fusions or C2-T2 for cervical fusions)
• Ability to undergo a reliable neurologic examination and pain assessments

You may not qualify if:

• Patients \<18 years of age
• Shorter-segment spinal fusions than those described above
• Undergoing current active cancer therapy
• Undergoing treatment with immunosuppressive drugs
• Additional spinal surgery within past 6 months
• Sustained bradycardia or presence of pacemaker
• History of substance abuse

Sponsors & Collaborators

• Alexander T. Yahanda: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Spinal Diseases; Neurologic Manifestations; Nervous System Diseases; Inflammation; Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pain

Central Study Contacts

Alexander T Yahanda, MD, MPHS

CONTACT

3143690198; ayahanda@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgery Resident

Model Details: Participants will be assigned to either the vagal nerve stimulation arm or the sham stimulation arm.

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 20, 2025
• Study Start: October 8, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)