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RecruitingNot ApplicableNCT07218133

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

Sponsor

Alexander T. Yahanda

Enrollment

50 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal fusion surgeryPostoperative Pain ManagementSpine FusionInflammationHyperglycemiaNeurological DisorderPostoperative CareSpinal FusionSpine DiseaseNeurologic DeficitsSpine ConditionCytokine Levels

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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

Exclusion Criteria7

  • 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

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Interventions

DEVICEAuricular vagus nerve stimulation

Transcutaneous auricular vagal nerve stimulation

DEVICESham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT07218133

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