Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU (TAVERN)

The Washington University

Status: Enrolling

Conditions: Acute Medical Conditions; Acute Neurological Injury

Treatments: Device: Auricular Vagus Nerve Stimulation; Device: Sham Auricular Vagus nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07219108

202507232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Auricular VNS Stimulation

Experimental group

Description:

Participants receive twice-daily auricular vagal nerve stimulation

Treatment:

Device: Auricular Vagus Nerve Stimulation

Sham Auricular VNS Stimulation

Sham Comparator group

Description:

Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied

Treatment:

Device: Sham Auricular Vagus nerve Stimulation