Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2027-09-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Neurological Injury Acute Medical Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either stimulation or sham stimulation arms

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Auricular VNS Stimulation

Participants receive twice-daily auricular vagal nerve stimulation

Group Type EXPERIMENTAL

Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

Transcutaneous auricular vagal nerve stimulation

Sham Auricular VNS Stimulation

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

Group Type SHAM_COMPARATOR

Sham Auricular Vagus nerve Stimulation

Intervention Type DEVICE

Transcutaneous auricular vagal nerve ear clip applied without current/stimulation

Interventions

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Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

Intervention Type DEVICE

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current/stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No