Auricular VNS Following Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Vagus Nerve Stimulation
Sham Auricular Vagus nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring Vagal nerve stimulation
Eligibility 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
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Auricular VNS Stimulation
Sham Auricular VNS Stimulation
Arm Description
Participants receive twice daily auricular vagal nerve stimulation
Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied
Outcomes
Primary Outcome Measures
Inflammatory markers in the serum on admission
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
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
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
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
Cerebral vasospasm
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
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
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
Presence of cerebral ischemia based on the following criteria: Radiographic evidence of a new infarct or stroke
Clinical outcome
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04557618
Brief Title
Auricular VNS Following Subarachnoid Hemorrhage
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Huguenard
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
Vagal nerve stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to either stimulation or sham stimulation arms
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Auricular VNS Stimulation
Arm Type
Experimental
Arm Description
Participants receive twice daily auricular vagal nerve stimulation
Arm Title
Sham Auricular VNS Stimulation
Arm Type
Sham Comparator
Arm Description
Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied
Intervention Type
Device
Intervention Name(s)
Auricular Vagus Nerve Stimulation
Intervention Description
Transcutaneous auricular vagal nerve stimulation
Intervention Type
Device
Intervention Name(s)
Sham Auricular Vagus nerve Stimulation
Intervention Description
Transcutaneous auricular vagal nerve ear clip applied without current
Primary Outcome Measure Information:
Title
Inflammatory markers in the serum on admission
Description
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
Time Frame
On hospital day 1
Title
Change in inflammatory markers in the serum
Description
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
Time Frame
Through hospital admission, average of 4 weeks
Title
Inflammatory markers in the CSF on admission
Description
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
Time Frame
On hospital day 1
Title
Change in inflammatory markers in the CSF on admission
Description
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
Time Frame
Through hospital admission, average of 4 weeks
Secondary Outcome Measure Information:
Title
Cerebral vasospasm
Description
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
Time Frame
Through hospital admission, average of 4 weeks
Title
Hydrocephalus
Description
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
Time Frame
Through hospital admission, average of 4 weeks
Title
Stressed-induced cardiomyopathy
Description
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
Time Frame
Through hospital admission, average of 4 weeks
Title
Cerebral ischemia
Description
Presence of cerebral ischemia based on the following criteria: Radiographic evidence of a new infarct or stroke
Time Frame
Through hospital admission, average of 4 weeks
Title
Clinical outcome
Description
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna L Huguenard, MD
Phone
3144506698
Email
ahuguenard@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C Leuthardt, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Huguenard, MD
Phone
314-450-6698
Email
ahuguenard@wustl.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Auricular VNS Following Subarachnoid Hemorrhage
We'll reach out to this number within 24 hrs