Evidence map›Paper›PMID 27412146›Full record

Trial reportNeurology2016

Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.

Stephen D Silberstein, Anne H Calhoun, Richard B Lipton, Brian M Grosberg, Roger K Cady, Stefanie Dorlas, Kristy A Simmons, Chris Mullin, Eric J Liebler, Peter J Goadsby and 2 more

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 114 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 13 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.

NCT01667250 nacompletednot on this map

Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine

TypeinterventionalSponsorElectroCore INCRan2012 to 2014Enrolled59ConditionsChronic MigraineArmsGammaCore Active Device, GammaCore Sham Device
NCT04071743 nawithdrawnnot on this mapstarted 2020, after this paper: background citation

A Randomized, Single-Center, Double-Blind, Parallel, Sham-Controlled Study of Gammacore Sapphire (Non-Invasive Vagus Nerve Stimulator) for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2020 to 2021Enrolled0ConditionsPost-Traumatic HeadacheArmsgammaCore Sapphire, sham gammaCore Sapphire
NCT04768738 nacompletednot on this mapstarted 2020, after this paper: background citation

The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals: Randomized, Double-Blind Study

TypeinterventionalSponsorSinop UniversityRan2020 to 2020Enrolled46ConditionsHealthy, Activity, MotorArmsAuricular Vagus Nerve Stimulation Level Of Above Threshold, Auricular Vagus Nerve Stimulation Level Of Subthreshold, Auricular Vagus Nerve Stimulation Sham Method, 5 Minutes Bicycle Exercise
3 · Its place in the literature

Who cites it

114 citing papers in PubMed, 13 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

54 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

12 authors.

Stephen D SilbersteinFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion. stephen.silberstein@jefferson.edu.
Anne H CalhounFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Richard B LiptonFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Brian M GrosbergFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Roger K CadyFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Stefanie DorlasFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Kristy A SimmonsFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Chris MullinFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Eric J LieblerFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Peter J GoadsbyFrom Jefferson Headache Center (S.D.S.), Philadelphia, PA; Carolina Headache Institute (A.H.C.), Chapel Hill, NC; Montefiore Headache Center and Albert Einstein College of Medicine (R.B.L.), Bronx, NY; Hartford HealthCare Headache Center (B.M.G.), West Hartford, CT; Clinvest Headache Care Center (R.K.C.), Springfield, MO; MedLogix Communications, LLC (S.D.), Schaumburg, IL; electroCore, LLC (K.A.S., E.J.L.), Basking Ridge, NJ; NAMSA (C.M.), Minneapolis, MN; University of California San Francisco (P.J.G.); King's College London (P.J.G.), UK; and Michigan Headache and Neurological Institute (J.R.S.), Ann Arbor. B.M.G. was affiliated with Montefiore Headache Center, Bronx, NY, at the time of study completion.
Joel R Saper
EVENT Study Group

Funding

Vascular Structure and Function in Cognitive AgingP01AG003949 · NIA · YESHIVA UNIVERSITY · PI Charles B Hall · 1985 to 2026
$73.9M
PREDICTORS OF COGNITIVE DECLINE IN NORMAL AGINGR01AG012101 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI DE LEON, MONY J., RUSINEK, HENRY · 1993 to 2015
$6.7M
Biomarkers in Early Alzheimer's Disease (AD).R01AG022374 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI DE LEON, MONY J., RUSINEK, HENRY · 2004 to 2015
$5.2M
TWO PRECLINICAL LATENT SCORES TO PREDICT OCCURRENCE OF DATR01AG034119 · NIA · WASHINGTON UNIVERSITY · PI XIONG, CHENGJIE · 2010 to 2014
$1.6M
Latent Mobility Abnormalities And FrailtyR01AG025119 · NIA · ALBERT EINSTEIN COL OF MED YESHIVA UNIV · PI VERGHESE, JOE · 2005 to 2009
$1.5M
NIA NIH HHS P01 AG003949NIA NIH HHS R01 AG012101NIA NIH HHS R01 AG022374NIA NIH HHS R01 AG025119NIA NIH HHS R01 AG034119
6 · The paper itself

Abstract

objectiveTo evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks.

methodsIn this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use.

resultsFifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01).

conclusionsTherapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. CLINICALTRIALSGOV IDENTIFIER: NCT01667250. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.

Indexed as

Vagus Nerve StimulationAdolescentAdultAgedDouble-Blind MethodFemaleHeadache DisordersHumansMaleMiddle AgedMigraine DisordersPilot ProjectsTreatment OutcomeYoung Adult

Identifiers

PMID27412146
PMCPMC4970666

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.