Auricular VNS Following Subarachnoid Hemorrhage

Overview

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

Full Title of Study: “Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2024

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.

Interventions

  • Device: Auricular Vagus Nerve Stimulation
    • Transcutaneous auricular vagal nerve stimulation
  • Device: Sham Auricular Vagus nerve Stimulation
    • Transcutaneous auricular vagal nerve ear clip applied without current

Arms, Groups and Cohorts

  • Experimental: Auricular VNS Stimulation
    • Participants receive twice daily auricular vagal nerve stimulation
  • Sham Comparator: Sham Auricular VNS Stimulation
    • Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied

Clinical Trial Outcome Measures

Primary Measures

  • Inflammatory markers in the serum on admission
    • Time Frame: On hospital day 1
    • IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from blood draws
  • Change in inflammatory markers in the serum
    • Time Frame: Through hospital admission, average of 4 weeks
    • IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from blood draws
  • Inflammatory markers in the CSF on admission
    • Time Frame: On hospital day 1
    • IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from cerebrospinal fluid
  • Change in inflammatory markers in the CSF on admission
    • Time Frame: Through hospital admission, average of 4 weeks
    • IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from cerebrospinal fluid

Secondary Measures

  • Cerebral vasospasm
    • Time Frame: Through hospital admission, average of 4 weeks
    • Presence of vasospasm based on any of the following criteria: 1) Radiographic evidence of vasospasm on CT angiogram or catheter angiogram, 2) Need for blood pressure augmentation or hypervolemia, 3) Need for intraarterial or intrathecal vasodilator, 4) Need for angioplasty
  • Hydrocephalus
    • Time Frame: Through hospital admission, average of 4 weeks
    • Presence of hydrocephalus based on any of the following criteria: 1) Need for temporary CSF diversion via an external ventricular drain, 2) Need for permanent CSF diversion via a ventricular shunt
  • Stressed-induced cardiomyopathy
    • Time Frame: Through hospital admission, average of 4 weeks
    • Presence of stressed-induced cardiomyopathy based on any of the following criteria: 1) New troponin elevation, 2) New EKG changes (specifically ST segment elevation, ST segment depression, left bundle branch block, prolonged QT interval), 3) New findings of cardiomyopathy on echocardiogram
  • Cerebral ischemia
    • Time Frame: Through hospital admission, average of 4 weeks
    • Presence of cerebral ischemia based on the following criteria: Radiographic evidence of a new infarct or stroke
  • Clinical outcome
    • Time Frame: 2 years
    • Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Anna Huguenard
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Anna Huguenard, Resident Physician – Washington University School of Medicine
  • Overall Official(s)
    • Eric C Leuthardt, MD, Principal Investigator, Washington University School of Medicine
  • Overall Contact(s)
    • Anna L Huguenard, MD, 3144506698, ahuguenard@wustl.edu

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