Evidence map›Paper›PMID 39921595›Full record

Observational studyEpilepsia2025

Vagus nerve stimulation in Lennox-Gastaut syndrome: Twenty-four-month data and experience from the CORE-VNS study.

Paul Lyons, James Wheless, Ryan Verner, Jose Ferreira, Kore Liow, James Valeriano, Gholam Motamedi, Gaia Giannicola, Kathryn Nichol

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Epilepsia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03529045 (CORE-VNS), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

NCT03529045 completednot on this map

CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy

Typeobservational_patient_registrySponsorLivaNovaRan2018 to 2024Enrolled827ConditionsEpilepsy, Seizures, Drug Resistant EpilepsyArmsVagus Nerve Stimulation (VNS) Therapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
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.

Paul LyonsVirginia Comprehensive Epilepsy Program, Winchester, Virginia, USA.
James WhelessUniversity of Tennessee Health Science Center and Le Bonheur Children's Hospital, Memphis, Tennessee, USA.ORCID https://orcid.org/0000-0002-4735-3431
Ryan VernerLivaNova, Houston, Texas, USA.ORCID https://orcid.org/0000-0002-7364-7978
Jose FerreiraDepartment of Pediatrics, and Pediatric Neurology, St. Joseph's Children's Hospital, School of Medicine, University of South Florida, Tampa, Florida, USA.
Kore LiowComprehensive Epilepsy Center, Hawaii Pacific Neuroscience, Honolulu, Hawaii, USA.
James ValerianoAllegheny General Hospital, Pittsburgh, Pennsylvania, USA.
Gholam MotamediDepartment of Neurology, Georgetown University Hospital, Washington, DC, USA.
Gaia GiannicolaLivaNova, London, UK.
Kathryn NicholLivaNova, Houston, Texas, USA.

Funding

LivaNova PLC
6 · The paper itself

Abstract

objectiveThe drug-resistant epilepsy associated with Lennox-Gastaut syndrome (LGS) has a long-term effect on patients and is difficult to treat with conventional pharmacological and nonpharmacological therapies. Our objective is to demonstrate that adjunctive vagus nerve stimulation (VNS) can help manage the seizures associated with LGS.

methodsCORE-VNS (NCT03529045) is a prospective, multicenter, multinational observational study to collect data on seizure and nonseizure outcomes following treatment with VNS. Participants were identified as having a documented LGS diagnosis and received initial VNS implants. Baseline seizure frequency data and patient-reported outcome measures were collected at 3, 6, 12, 24, and 36 months. This interim analysis compared baseline data to VNS therapy outcomes at 24 months, and the results are presented here.

resultsSixty participants in the CORE-VNS study had a diagnosis of LGS and received an initial implant of VNS. The population was geographically diverse: 31.7% European, 26.7% from the Americas, and 26.7% from the Western Pacific. The median age at implant was 11.8 years (range = 2.2-47.6), and only 26.7% of those diagnosed with LGS were >18 years of age. Most (70%) of the participants had severe cognitive impairment. The LGS participants failed a median of 6 antiseizure medications, and 83.3% had not undergone epilepsy surgery. The LGS responder rate (≥50% reduction in seizure frequency) at 24 months for focal and generalized seizures was 66.7% and 47.4%, respectively. Some participants (20%, 12/60) experienced a ≥80% reduction in total seizure frequency. VNS was well tolerated, with only 15% (9/60) reporting at least one treatment-emergent adverse event, primarily cough, dysphonia, and oropharyngeal pain. SIGNIFICANCE: LGS participants who received adjunctive VNS therapy to manage seizures were predominantly severely cognitively impaired children. Reductions in seizure frequency, including those with drops, and the sustained nature of the response support VNS as a promising therapy in LGS.

Indexed as

Lennox Gastaut SyndromeVagus Nerve StimulationAdolescentAdultChildChild, PreschoolDrug Resistant EpilepsyFemaleHumansMaleProspective StudiesTreatment OutcomeYoung Adultatonicfocal to bilateralgeneralized tonic–clonicneuromodulationseizurestonic–clonic

Identifiers

PMID39921595
PMCPMC12097468

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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.