Auricular VNS Following Subarachnoid Hemorrhage

  • STATUS
    Recruiting
  • End date
    Oct 20, 2025
  • participants needed
    80
  • sponsor
    Anna Huguenard
Updated on 22 December 2021

Summary

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.

Details
Condition Subarachnoid Hemorrhage
Treatment Auricular vagus nerve stimulation, Sham Auricular Vagus nerve Stimulation
Clinical Study IdentifierNCT04557618
SponsorAnna Huguenard
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

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
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