Abstract
BackgroundSecondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume.MethodsNOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI.DiscussionWe hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke.Trial registrationClinicalTrials.govNCT04050501. Registered on 8 August 2019
Highlights
Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome
Current treatment options for acute ischemic stroke patients are the lysis of the clot that obstructs the intracerebral blood vessel by intravenous thrombolysis (IVT) or removal of the clot with endovascular treatment (EVT) [1, 2]
One hundred fifty patients admitted for an acute ischemic stroke in the Leiden University Medical Center will be randomly assigned (1:1) to treatment with non-invasive cervical vagus nerve stimulation (VNS) (nVNS) in addition to standard treatment or standard treatment alone
Summary
Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. After occlusion of an intracerebral blood vessel, part of the brain tissue supplied by this vessel (the ischemic core) dies immediately. In the first days after ischemic stroke, expansion of the ischemic core into the penumbra leads to secondary damage, which contributes substantially to poor outcomes [6]. SDs develop and propagate in the penumbra where they cause decreased blood flow and eventually infarction of the viable tissue. In this way, van der Meij et al Trials (2020) 21:878
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