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NCT06799390NARecruiting

Auricular VNS Following Intracerebral Hemorrhage

Washington University School of Medicine

Start Date

4/6/2025

Completion Date

2/9/2032

Summary

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.

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 inflammatory markers in the blood and cerebrospinal fluid (CSF) in patients with intracerebral hemorrhage, and how it impacts their clinical course and outcomes. This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the development of peri-hematomal edema, interventions for edema (medical or surgical), and intensive care unit and hospital stay. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge. No additional appointments will be made specially for the research study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital Exclusion Criteria: * Patients \< 18 years old * Patients with a presumed traumatic etiology for their ICH, infratentorial location, ICH volume \> 60 ml or \< 10 ml, at risk of imminent death (e.g. Glasgow Coma Scale, GCS of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy) * Patients undergoing active cancer therapy * Patients with sustained bradycardia on arrival with a heart rate \< 50 beats per minute. * Patients who cannot be enrolled within 48 hours of the initial bleed.

Interventions

DEVICE

Auricular Vagus Nerve Stimulation

DEVICE

Sham Auricular Vagus nerve Stimulation

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Conditions

Intracerebral Hemorrhage

Locations

Washington University School of Medicine

St Louis, Missouri 63110

United States