Evidence map›Paper›PMID 27593728›Full record

Trial reportHeadache2016

Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study.

Stephen D Silberstein, Laszlo L Mechtler, David B Kudrow, Anne H Calhoun, Candace McClure, Joel R Saper, Eric J Liebler, Emily Rubenstein Engel, Stewart J Tepper, ACT1 Study Group

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01792817 (Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache), which is not on this map. Cited by 117 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 6 pooled it
22.7field-weighted citation impact, top 1% 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.

NCT01792817 nacompletednot on this map

Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache

TypeinterventionalSponsorElectroCore INCRan2013 to 2014Enrolled150ConditionsCluster HeadacheArmsGammaCore, Sham GammaCore device
3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 6 syntheses or guidelines pooled it, 250 citations in OpenAlex.

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57 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 1 country.

Stephen D SilbersteinDepartment of Neurology, Jefferson Headache Center, Philadelphia, PA, USA. stephen.silberstein@jefferson.edu.
Laszlo L MechtlerDepartment of Neurology and Neuro-Oncology, Dent Neurologic Headache Center, Amherst, NY, USA.
David B KudrowCalifornia Medical Clinic for Headache, Santa Monica, CA, USA.
Anne H CalhounCarolina Headache Institute, Durham, NC, USA.
Candace McClureNorth American Science Associates Inc, Minneapolis, MN, USA.
Joel R SaperMichigan Head Pain and Neurological Institute, Ann Arbor, MI, USA.
Eric J LieblerDepartment of Scientific, Medical and Governmental Affairs, electroCore, LLC, Basking Ridge, NJ, USA.
Emily Rubenstein EngelDalessio Headache Center at Scripps Clinic, La Jolla, CA, USA.
Stewart J TepperDepartment of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.
ACT1 Study Group
American Academy of Neurology · USCalifornia Medical Clinic for Headache · USCarolina Headache Institute · USDartmouth College · USDent Neurologic Institute · USJefferson College · USMichigan Headache and Neurological Institute · USScripps Clinic · USVencore (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.

backgroundMany patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.

methodsOne hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified.

resultsThe intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects (P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort (P = .008) and total population (P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred.

conclusionsIn one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. ClinicalTrials.gov identifier: NCT01792817.

Indexed as

Cluster HeadacheDouble-Blind MethodFemaleHumansMaleMiddle AgedPain MeasurementTreatment OutcomeUnited StatesVagus Nerve Stimulationacute treatmentchronic cluster headacheepisodic cluster headacheneuromodulationnon-invasive vagus nerve stimulationrandomized controlled trial

Identifiers

PMID27593728
PMCPMC5113831
OpenAlexW2509261887

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.