Evidence map›Paper›PMID 33106174›Full record

ArticleTrials2020

NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial.

Anne van der Meij, Marianne A A van Walderveen, Nyika D Kruyt, Erik W van Zwet, Eric J Liebler, Michel D Ferrari, Marieke J H Wermer

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04050501 nacompletednot on this map

Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke

TypeinterventionalSponsorLeiden University Medical CenterRan2019 to 2025Enrolled150ConditionsIschemic StrokeArmsnon-invasive Vagus Nerve Stimulator
NCT05103566 narecruitingnot on this mapstarted 2022, after this paper: background citation

STORM: Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage

TypeinterventionalSponsorMassachusetts General HospitalRan2022 to 2029Enrolled25ConditionsSubarachnoid Hemorrhage, AneurysmalArmsgammaCore
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Cytoprotection Concepts for Ischemic Stroke in the Recanalization Era.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  3. Article
  4. The evolution of neuromodulation for chronic stroke: From neuroplasticity mechanisms to brain-computer interfaces.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024
    Review
  5. A narrative review of vagus nerve stimulation in stroke.Journal of central nervous system disease · 2024
    Review
  6. Article
  7. Vagus Nerve Stimulation in Ischemic Stroke.Current neurology and neuroscience reports · 2023
    Review
  8. Neuroinflammation in Acute Ischemic and Hemorrhagic Stroke.Current neurology and neuroscience reports · 2023
    Review
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Anne van der MeijDepartment of Neurology, Leiden University Medical Center, Leiden, the Netherlands. a.van_der_meij@lumc.nl.ORCID http://orcid.org/0000-0001-8661-1213
Marianne A A van WalderveenDepartment of Radiology, Leiden University Medical Center, Leiden, the Netherlands.
Nyika D KruytDepartment of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
Erik W van ZwetDepartment of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.
Eric J LieblerelectroCore, Inc, Basking Ridge, NJ, USA.
Michel D FerrariDepartment of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
Marieke J H WermerDepartment of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
Leiden University Medical Center · NL

Funding

electroCore Inc unrestricted funding including the devicesNederlandse Organisatie voor Wetenschappelijk Onderzoek 91717337
6 · The paper itself

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. 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 registrationClinicalTrials.gov NCT04050501 . Registered on 8 August 2019.

Indexed as

Brain IschemiaIschemic StrokeStrokeVagus Nerve StimulationAnimalsHumansProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeAcute ischemic strokePenumbraRandomized controlled trialSecondary damageSpreading depolarizationsVagus nerve stimulation

Identifiers

PMID33106174
PMCPMC7586413
OpenAlexW3094158089

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.