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Auricular VNS Following Subarachnoid Hemorrhage

Auricular VNS Following Subarachnoid Hemorrhage

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

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

Study details
    Subarachnoid Hemorrhage

NCT04557618

Anna Huguenard

28 January 2024

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