This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Transcutaneous auricular vagal nerve stimulation
Transcutaneous auricular vagal nerve ear clip applied without current
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGInflammatory markers in the serum on admission
TNF alpha from blood draw
Time frame: On hospital day 1
Change in inflammatory markers in the serum
TNF alpha from blood draws
Time frame: Through hospital admission, average of 4 weeks
Inflammatory markers in the CSF on admission
TNF alpha from cerebrospinal fluid
Time frame: On hospital day 1
Change in inflammatory markers in the CSF
TNF alpha from cerebrospinal fluid
Time frame: Through hospital admission, average of 4 weeks
Cerebral vasospasm
Presence of moderate/severe radiographic vasospasm
Time frame: Through hospital admission, average of 4 weeks
Hydrocephalus
Need for permanent CSF diversion via a ventricular shunt
Time frame: Through hospital admission, average of 4 weeks
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-8from blood draws
Time frame: On hospital day 1
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 from blood draws
Time frame: Through hospital admission, average of 4 weeks
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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, from cerebrospinal fluid
Time frame: On hospital day 1
Change in inflammatory markers in the CSF
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
Time frame: Through hospital admission, average of 4 weeks
Cerebral vasospasm
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
Time frame: Through hospital admission, average of 4 weeks
Cerebral ischemia
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
Hydrocephalus
Duration of temporary CSF diversion via an external ventricular drain
Time frame: Through hospital admission, average of 4 weeks
Clinical outcome
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Time frame: 2 years
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
Time frame: Through hospital admission, average of 4 weeks