Auricular VNS Following Subarachnoid Hemorrhage
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Inflammatory markers in the serum on admission [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 [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 [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 [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
- Cerebral vasospasm [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 [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 [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 [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 [2 years]
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Anna Huguenard
Investigators
- Principal Investigator: Eric C Leuthardt, MD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202007034