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Recruiting NCT07219108

Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

No phase Interventional Acute Neurological Injury Acute Medical Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricular Vagus Nerve Stimulation, Sham Auricular Vagus nerve Stimulation.
Who it may be relevant to
Registry conditions: Acute Neurological Injury, Acute Medical Conditions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Assessment of the need for tracheostomy. [Time frame: 14 days]
  • Occurrence of hospital-acquired infections [Time frame: 14 days]
  • Changes in heart rate/heart trace [Time frame: 14 days]
  • Blood glucose measurement [Time frame: 14 days]
  • Insulin requirement [Time frame: 14 days]
  • Hospital length of stay [Time frame: Through hospital admission, average 14 days]
  • Neurological outcome [Time frame: 1 year]
  • Discharge destination [Time frame: After hospital discharge, on average 14 days after admission.]
  • Cost of ICU stay [Time frame: Through hospital admission, average 14 days]
  • Cost of Hospital Admission [Time frame: Through hospital admission, average 14 days]
Secondary outcome measures (9)
  • Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma [Time frame: 14 days]
  • Change in inflammatory markers in cerebrospinal fluid [Time frame: 14 days]
  • Cerebral Edema [Time frame: 14 days]
  • Neurological outcome at discharge and first follow-up [Time frame: up to 1 year.]
  • Neurological Outcome at discharge and first follow-up [Time frame: up to 1 year.]
  • Neurological Outcome at discharge and first follow-up [Time frame: Up to 1 year.]
  • Neurological Outcome at discharge and first follow-up. [Time frame: Up to 1 year.]
  • Diagnosis of hospital-acquired infections [Time frame: Through hospital admission, average 14 days]
  • Use of a ventilator [Time frame: Through hospital admission, average 14 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Publications

  • Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088. PMID 39786346
  • Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024. PMID 39178291
  • Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598. PMID 38746275

Identifiers

NCT: NCT07219108 · 202507232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗