NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial
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NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial Anne van der Meij1* , Marianne A. A. van Walderveen2, Nyika D. Kruyt1, Erik W. van Zwet3, Eric J. Liebler4, Michel D. Ferrari1 and Marieke J. H. Wermer1
Abstract Background: Secondary 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. Methods: NOVIS 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. Discussion: We 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 registration: ClinicalTrials.gov NCT04050501. Registered on 8 August 2019 Keywords: Acute ischemic stroke, Vagus nerve stimulation, Spreading depolarizations, Penumbra, Secondary damage, Randomized controlled trial
Background 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]. Unfortunately, only a small number of patients are eligible for these therapies and, when treated, the clinical outcome remains poor in two out of three patients [3–5]. * Correspondence: [email protected] 1 Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands Full list of author information is available at the end of the article
After occlusion of an intracerebral blood vessel, part of the brain tissue supplied by this vessel (the ischemic core) dies immediately. The ischemic core is surrounded by the penumbra, an area with compromised perfusion but still viable tissue. 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]. Spreading depolarizations (SDs) are waves of neuroglial depolarizations leading to cytotoxic edema and silencing of brain activity. SDs develop and propagate in the penumbra where they cause decreased blood flow and eventually infarction of the viable tissue. In this way,
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