Evidence map›Paper›PMID 26391457›Full record

Trial reportCephalalgia : an international journal of headache2016

Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.

Charly Gaul, Hans-Christoph Diener, Nicholas Silver, Delphine Magis, Uwe Reuter, Annelie Andersson, Eric J Liebler, Andreas Straube, PREVA Study Group

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 113 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 10 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  9. Cluster headache: crosspoint between otologists and neurologists-treatment of the sphenopalatine ganglion and systematic review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
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53 more citing papers are in PubMed but not listed here.

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

9 authors.

Charly GaulMigraine and Headache Clinic, Königstein, Germany c.gaul@migraene-klinik.de.
Hans-Christoph DienerDepartment of Neurology, University Hospital-Essen, Essen, Germany.
Nicholas SilverWalton Centre for Neurology and Neurosurgery, Liverpool, UK.
Delphine MagisLiège University, Liège, Belgium.
Uwe ReuterDepartment of Neurology, Charité University Hospital, Berlin, Germany.
Annelie AnderssonelectroCore GMBH, Gothenburg, Sweden.
Eric J LieblerelectroCore, LLC, Basking Ridge, NJ, USA.
Andreas StraubeLudwig Maximilian University of Munich, Munich, Germany.
PREVA Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic cluster headache (CH) is a debilitating disorder for which few well-controlled studies demon.strate effectiveness of available therapies. Non-invasive vagus nerve stimulation (nVNS) was examined as adjunctive prophylactic treatment of chronic CH.

methodsPREVA was a prospective, open-label, randomised study that compared adjunctive prophylactic nVNS (n = 48) with standard of care (SoC) alone (control (n = 49)). A two-week baseline phase was followed by a four-week randomised phase (SoC plus nVNS vs control) and a four-week extension phase (SoC plus nVNS). The primary end point was the reduction in the mean number of CH attacks per week. Response rate, abortive medication use and safety/tolerability were also assessed.

resultsDuring the randomised phase, individuals in the intent-to-treat population treated with SoC plus nVNS (n = 45) had a significantly greater reduction in the number of attacks per week vs controls (n = 48) (-5.9 vs -2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; p = 0.02). Higher ≥50% response rates were also observed with SoC plus nVNS (40% (18/45)) vs controls (8.3% (4/48); p < 0.001). No serious treatment-related adverse events occurred.

conclusionAdjunctive prophylactic nVNS is a well-tolerated novel treatment for chronic CH, offering clinical benefits beyond those with SoC.

Indexed as

AdultCluster HeadacheFemaleHumansMaleMiddle AgedVagus Nerve Stimulationadjunctive prophylaxiscluster headacheNeuromodulationvagus nerve

Identifiers

PMID26391457
PMCPMC4853813

What OpenQuestion holds

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Registered trials

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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.