RecruitingNot ApplicableNCT07219108

Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

The TAVERN Trial: Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU - A Study of Clinical Outcomes and Cost Reduction


Sponsor

Washington University School of Medicine

Enrollment

160 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical care population.


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • Age ≥18
  • Admission to the NeuroICU within 36 hours of onset of an acute medical condition.
  • Patient or authorized legal representative should be able to provide consent within 36 hours of ICU arrival
  • Presence of at least one predictor of critical illness and/or severe brain / spinal cord injury:
  • Glasgow Coma Scale GCS \>3 \& \<= 12 at admission
  • NIH stroke scale of 6 or greater
  • Requirement for ongoing mechanical ventilation
  • Requirement for ongoing vasopressor support
  • Diagnosis of subarachnoid hemorrhage
  • Diagnosis of intracerebral hemorrhage with hematoma volume \> 5 ml
  • Diagnosis of moderate-severe traumatic brain injury (GCS \>3 \& \<= 12)
  • Refractory Status epilepticus requiring continuous sedative infusions

Exclusion Criteria8

  • Systemic immunosuppression
  • Receiving ongoing cancer therapy
  • Implanted electrical device (e.g., pacemaker, stimulator)
  • Bradycardia on admission (Sustained bradycardia on arrival with a heart rate \< 50 bpm for \>5 minutes)
  • Risk of imminent death or limitation of care (e.g., Glasgow Coma Scale of 3, pupillary dilatation)
  • Expected ICU stay of less than 72 hours, as determined by attending physician or ICU fellow
  • Pregnancy
  • COVID-19

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Interventions

DEVICEAuricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

DEVICESham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current/stimulation


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT07219108


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