Auricular VNS Following Subarachnoid Hemorrhage
- Conditions
- Subarachnoid Hemorrhage
- Interventions
- Device: Sham Auricular Vagus nerve StimulationDevice: Auricular Vagus Nerve Stimulation
- Registration Number
- NCT04557618
- Lead Sponsor
- Anna Huguenard
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Spontaneous subarachnoid hemorrhage
- Trauma-induced subarachnoid hemorrhage
- Ongoing chemotherapy
- Taking immunosuppressive medications for other medical illnesses
- Presence of a pacemaker
- Prolonged bradycardia at time of admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Auricular VNS Stimulation Sham Auricular Vagus nerve Stimulation Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied Auricular VNS Stimulation Auricular Vagus Nerve Stimulation Participants receive twice daily auricular vagal nerve stimulation
- Primary Outcome Measures
Name Time Method Change in inflammatory markers in the CSF Through hospital admission, average of 4 weeks TNF alpha from cerebrospinal fluid
Cerebral vasospasm Through hospital admission, average of 4 weeks Presence of moderate/severe radiographic vasospasm
Hydrocephalus Through hospital admission, average of 4 weeks Need for permanent CSF diversion via a ventricular shunt
Inflammatory markers in the serum on admission On hospital day 1 TNF alpha from blood draw
Change in inflammatory markers in the serum Through hospital admission, average of 4 weeks TNF alpha from blood draws
Inflammatory markers in the CSF on admission On hospital day 1 TNF alpha from cerebrospinal fluid
- Secondary Outcome Measures
Name Time Method 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-8from 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 from blood draws
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
Hydrocephalus Through hospital admission, average of 4 weeks Duration of temporary CSF diversion via an external ventricular drain
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
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, from cerebrospinal fluid
Cerebral vasospasm Through hospital admission, average of 4 weeks Additional features of vasospasm: 1) Number of vascular studies obtained, 2) Need for blood pressure augmentation or hypervolemia, 3) Need for intraarterial or intrathecal vasodilator, 4) Need for angioplasty
Change in inflammatory markers in the CSF 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, from cerebrospinal fluid
Clinical outcome 2 years Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States