Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Not Applicable

Recruiting

• Conditions: Acute Neurological Injury; Acute Medical Conditions

• Registration Number: NCT07219108
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2025-09-24
• Status Verified: 2025-10
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-20
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Primary Completion: 2027-09-23
• Study Completion: 2027-09-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of the need for tracheostomy.	14 days	Quantification of patients who need tracheostomy due to prolonged intubation.
Cost of Hospital Admission	Through hospital admission, average 14 days	Evaluation of total hospital admission cost of stay ($)
Occurrence of hospital-acquired infections	14 days	Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
Changes in heart rate/heart trace	14 days	Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
Blood glucose measurement	14 days	Daily evaluation of blood glucose (mg/dL)
Insulin requirement	14 days	Assessment of daily insulin requirement (Units)
Hospital length of stay	Through hospital admission, average 14 days	Total length of stay in the hospital, and in the intensive care unit
Neurological outcome	1 year	Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Discharge destination	After hospital discharge, on average 14 days after admission.	Patient discharge destination (ie, home, acute rehab)
Cost of ICU stay	Through hospital admission, average 14 days	Evaluation of total ICU cost of stay ($)

Secondary Outcome Measures

Name	Time	Method
Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma	14 days	Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
Change in inflammatory markers in cerebrospinal fluid	14 days	rebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for TNF-α, IL-6, IL-10, and IFN-γ . Inflammatory markers will be reported in pg/mL.
Cerebral Edema	14 days	Assessment of cerebral edema on each medically indicated and obtained head CT scan through assessment of selective sulcal volume (SSV)
Neurological outcome at discharge and first follow-up	up to 1 year.	Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Neurological Outcome at discharge and first follow-up	Up to 1 year.	Disease-specific neurological outcome metric at discharge and first follow-up. Hemorrhagic stroke Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Neurological Outcome at discharge and first follow-up.	Up to 1 year.	Disease-specific neurological outcome metric at discharge and first follow-up. National Institutes of Health Stroke Scale (NIHSS, maximum score: 42; minimum score: 1; better outcomes have lower scores).
Diagnosis of hospital-acquired infections	Through hospital admission, average 14 days	Binary assessment of hospital-acquired infections (ventilator-associated pneumonia, catheter associated urinary tract infection, Clostridium difficile infection, ventriculitis) diagnosis acquired from hospital databases. (Yes or No rating, better outcomes associated with No).
Use of a ventilator	Through hospital admission, average 14 days	Quantification of days on ventilator

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States