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NCT04557618NARecruiting

Auricular VNS Following Subarachnoid Hemorrhage

Anna Huguenard

Start Date

1/5/2021

Completion Date

12/1/2028

Summary

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

Detailed Description

Vagal nerve stimulation (VNS) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (SAH) with promising results. The purpose of the proposed study is to determine how applying auricular VNS in patients presenting with spontaneous SAH impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (CSF), 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 development of cerebral vasospasm, need for CSF diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Spontaneous subarachnoid hemorrhage Exclusion Criteria: * Trauma-induced subarachnoid hemorrhage * Ongoing chemotherapy * Taking immunosuppressive medications for other medical illnesses * Presence of a pacemaker * Prolonged bradycardia at time of admission

Interventions

DEVICE

Auricular Vagus Nerve Stimulation

DEVICE

Sham Auricular Vagus nerve Stimulation

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Conditions

Subarachnoid Hemorrhage

Locations

Washington University School of Medicine

St Louis, Missouri 63110

United States