Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Purpose

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.

Conditions

  • Acute Neurological Injury
  • Acute Medical Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants are assigned to either stimulation or sham stimulation arms
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores and measures will be assessed and recorded by clinicians and research team members blinded to the treatment arm.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Auricular VNS Stimulation 		Participants receive twice-daily auricular vagal nerve stimulation
  • Device: Auricular Vagus Nerve Stimulation
    Transcutaneous auricular vagal nerve stimulation
  • Device: Sham Auricular Vagus nerve Stimulation
    Transcutaneous auricular vagal nerve ear clip applied without current/stimulation
Sham Comparator
Sham Auricular VNS Stimulation 		Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied
  • Device: Sham Auricular Vagus nerve Stimulation
    Transcutaneous auricular vagal nerve ear clip applied without current/stimulation

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Juliana Amaral Passipieri, PhD
314-747-1443
ajuliana@wustl.edu

More Details

NCT ID
NCT07219108
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Raj Dhar, MD
314-362 2999
dharr@wustl.edu

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.