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.govNCT04050501. Registered on 8 August 2019

Details

Title
NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial
Author
van der Meij, Anne 1   VIAFID ORCID Logo  ; van Walderveen, Marianne A. A. 2 ; Kruyt, Nyika D. 1 ; van Zwet, Erik W. 3 ; Liebler, Eric J. 4 ; Ferrari, Michel D. 1 ; Wermer, Marieke J. H. 1 

1  Leiden University Medical Center, Department of Neurology, Leiden, the Netherlands (GRID:grid.10419.3d) (ISNI:0000000089452978) 
2  Leiden University Medical Center, Department of Radiology, Leiden, the Netherlands (GRID:grid.10419.3d) (ISNI:0000000089452978) 
3  Leiden University Medical Center, Department of Medical Statistics, Leiden, the Netherlands (GRID:grid.10419.3d) (ISNI:0000000089452978) 
4  electroCore, Inc, Basking Ridge, USA (GRID:grid.10419.3d) 
Pages
878
Publication year
2020
Publication date
Dec 2020
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-020-04794-1
ProQuest document ID
2812313940
Copyright
© The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.