NCT07219108NARecruiting

Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Washington University School of Medicine

Start Date

9/24/2025

Completion Date

9/23/2027

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.

Detailed Description

Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact 1) the occurrence of hospital-acquired infections, 2) the need for tracheostomy due to prolonged intubation, 3) the effect on hospital-stay physiology (e.g., vital signs and blood glucose metrics), and 4) inflammatory markers in the blood, and 5) the health economics. This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood samples for inflammatory marker analysis will be collected upon admission and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the occurrence of hospital-acquired infections, tracheostomy, changes in vital signs and blood glucose, development of peri-hematomal edema, and interventions for edema (medical or surgical). Outcomes following admission will include intensive care unit and hospital stay, cost analysis of hospital stay, discharge destination, functional scores at discharge, and at follow-up visits for up to 1 year after discharge. No additional appointments will be made specially for the research study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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

Interventions

DEVICE

Auricular Vagus Nerve Stimulation

DEVICE

Sham Auricular Vagus nerve Stimulation

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Conditions

Acute Neurological InjuryAcute Medical Conditions

Locations

Washington University School of Medicine

St Louis, Missouri 63110

United States