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Auricular VNS Following Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT04557618
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Anna Huguenard, Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Device: Auricular Vagus Nerve Stimulation Device: Sham Auricular Vagus nerve Stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to either stimulation or sham stimulation arms
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.
Primary Purpose: Treatment
Official Title: Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Auricular VNS Stimulation
Participants receive twice daily auricular vagal nerve stimulation
 Device: Auricular Vagus Nerve Stimulation
Transcutaneous 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
 Device: Sham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Clinical outcome [ Time Frame: 2 years ]
    Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557618


Contacts
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Contact: Anna L Huguenard, MD 3144506698 ahuguenard@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Anna Huguenard, MD    314-450-6698    ahuguenard@wustl.edu   
Sponsors and Collaborators
Anna Huguenard
Investigators
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Principal Investigator: Eric C Leuthardt, MD Washington University School of Medicine
More Information
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Responsible Party: Anna Huguenard, Resident Physician, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04557618    
Other Study ID Numbers: 202007034
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Anna Huguenard, Washington University School of Medicine:
Vagal nerve stimulation
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases