- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557618
Auricular VNS Following Subarachnoid Hemorrhage
Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna L Huguenard, MD
- Phone Number: 3144506698
- Email: ahuguenard@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Anna Huguenard, MD
- Phone Number: 314-450-6698
- Email: ahuguenard@wustl.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auricular VNS Stimulation
Participants receive twice daily auricular vagal 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
|
Transcutaneous auricular vagal nerve ear clip applied without current
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
On hospital day 1
|
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
|
Through hospital admission, average of 4 weeks
|
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
|
On hospital day 1
|
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
|
Through hospital admission, average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Through hospital admission, average of 4 weeks
|
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
|
Through hospital admission, average of 4 weeks
|
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
|
Through hospital admission, average of 4 weeks
|
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
|
Through hospital admission, average of 4 weeks
|
Clinical outcome
Time Frame: 2 years
|
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric C Leuthardt, MD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202007034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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