Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Alexander T. Yahanda
Study ID
NCT07218133
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Auricular vagus nerve stimulation — DEVICE
    Transcutaneous auricular vagal nerve stimulation
  • Sham Auricular Vagus nerve Stimulation — DEVICE
    Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Study Details

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.

Key Dates

Start date
Oct 8, 2025
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Auricular vagal nerve stimulation
    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
  • Sham Comparator: Sham vagal nerve stimulation
    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.

Primary Outcome Measure

Inflammatory cytokine levels [ Time Frame: 5-10 days (depending on hospital admission length) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Alexander T Yahanda, MD, MPHS
[email protected]
2604946828
Eric C Leuthardt, MD (PRINCIPAL_INVESTIGATOR)
Camilo A Molina, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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