BMJ Neurology Open (Dec 2021)
Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry
- ,
- Terry O’Brien,
- Patrick Kwan,
- Markus Reuber,
- Arjune Sen,
- Rhys Thomas,
- Lakshmi Nagarajan,
- Muhammad Zafar,
- Mark Keezer,
- Paul Lyons,
- George Morris,
- Andrea Andrade,
- David McCormick,
- Paolo Tinuper,
- Jorge Burneo,
- Michael Gelfand,
- Kristl Vonck,
- Yongjie Li,
- Kate Riney,
- Anto Bagic,
- Ryan Verner,
- James P Valeriano,
- Ricky Lee,
- Katarzyna Kotulska,
- Ellen Jespers,
- Maxine Dibué,
- Simon Harvey,
- Tim von Oertzen,
- Riem El Tahry,
- Andréa Julião deOliveira,
- Isabella D’Andrea Meira,
- Martin Veilleux,
- Kenneth Myers,
- GuoMing Luan,
- Fangcheng Li,
- JiWen Xu,
- Raja Sarma Gosala,
- Vrajesh Udani,
- Nilesh Kurwale,
- Michal Tzadok,
- Firas Fahoum,
- Hadassa Goldberg-Stern,
- Nicola Specchio,
- Seijiro Shimada,
- Tomonori Ono,
- Boudewijn Gunning,
- Louis Wagner,
- Rinze Neuteboom,
- Ewa Krzystanek,
- Youssef Al-Said,
- Mashael Omar Alkhateeb,
- Kasia Sieradzan,
- Jeffrey Cochius,
- Karen Keough,
- Marc Frost,
- Marie Collier,
- Kore Liow,
- Jane Boggs,
- Ahmed Sadek,
- James Wheless,
- James Valeriano,
- Linda Leary,
- Xiangping Zhou,
- Jose Ferreira,
- Gholam Motamedi,
- Masaki Iwasaki
Affiliations
- Department of Clinical Surgery, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK
- Terry O’Brien
- Patrick Kwan
- Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Victoria, Australia
- Markus Reuber
- Academic Neurology Unit, Royal Hallamshire Hospital, The University of Sheffield, Sheffield, UK
- Arjune Sen
- Oxford Epilepsy Research Group, NIHR Biomedical Research Centre, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
- Rhys Thomas
- Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
- Lakshmi Nagarajan
- Muhammad Zafar
- Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA
- Mark Keezer
- Department of Neuroscience, University of Montreal, Montreal, Quebec, Canada
- Paul Lyons
- Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK
- George Morris
- Andrea Andrade
- David McCormick
- Paolo Tinuper
- Jorge Burneo
- Michael Gelfand
- Kristl Vonck
- Yongjie Li
- Kate Riney
- Anto Bagic
- Ryan Verner
- Clinical and Medical Affairs, LivaNova Plc, London, UK
- James P Valeriano
- Allegheny General Hospital, Pittsburgh, Pennsylvania, USA
- Ricky Lee
- Department of Neurology, Ascension Medical Group, Wichita, Kansas, USA
- Katarzyna Kotulska
- Department of Neurology and Epileptology, Children`s Memorial Health Institute, Warszawa, Poland
- Ellen Jespers
- Clinical and Medical Affairs, LivaNova Plc, London, UK
- Maxine Dibué
- Clinical and Medical Affairs, LivaNova Plc, London, UK
- Simon Harvey
- Tim von Oertzen
- Riem El Tahry
- Andréa Julião deOliveira
- Isabella D’Andrea Meira
- Martin Veilleux
- Kenneth Myers
- GuoMing Luan
- Fangcheng Li
- JiWen Xu
- Raja Sarma Gosala
- Vrajesh Udani
- Nilesh Kurwale
- Michal Tzadok
- Firas Fahoum
- Hadassa Goldberg-Stern
- Nicola Specchio
- Seijiro Shimada
- Tomonori Ono
- Boudewijn Gunning
- Louis Wagner
- Rinze Neuteboom
- Ewa Krzystanek
- Youssef Al-Said
- Mashael Omar Alkhateeb
- Kasia Sieradzan
- Jeffrey Cochius
- Karen Keough
- Marc Frost
- Marie Collier
- Kore Liow
- Jane Boggs
- Ahmed Sadek
- James Wheless
- James Valeriano
- Linda Leary
- Xiangping Zhou
- Jose Ferreira
- Gholam Motamedi
- Masaki Iwasaki
- DOI
- https://doi.org/10.1136/bmjno-2021-000218
- Journal volume & issue
-
Vol. 3,
no. 2
Abstract
Introduction The Vagus Nerve Stimulation Therapy System (VNS Therapy) is an adjunctive neuromodulatory therapy that can be efficacious in reducing the frequency and severity of seizures in people with drug-resistant epilepsy (DRE). CORE-VNS aims to examine the long-term safety and clinical outcomes of VNS in people with DRE.Methods and analysis The CORE-VNS study is an international, multicentre, prospective, observational, all-comers, post-market registry. People with DRE receiving VNS Therapy for the first time as well as people being reimplanted with VNS Therapy are eligible. Participants have a baseline visit (prior to device implant). They will be followed for a minimum of 36 months and a maximum of 60 months after implant. Analysis endpoints include seizure frequency (average number of events per month), seizure severity (individual-rated categorical outcome including very mild, mild, moderate, severe or very severe) as well as non-seizure outcomes such as adverse events, use of antiseizure medications, use of other non-pharmacological therapies, quality of life, validated measures of quality of sleep (Pittsburgh Sleep Quality Index or Children’s Sleep Habit Questionnaire) and healthcare resource utilisation. While the CORE-VNS registry was not expressly designed to test hypotheses, subgroup analyses and exploratory analysis that require hypothesis testing will be conducted across propensity score matched treatment groups, where possible based on sampling.Ethics and dissemination The CORE-VNS registry has already enrolled 823 participants from 61 centres across 15 countries. Once complete, CORE-VNS will represent one of the largest real-world clinical data sets to allow a more comprehensive understanding of the management of DRE with adjunctive VNS. Manuscripts derived from this database will shed important new light on the characteristics of people receiving VNS Therapy; the practical use of VNS across different countries, and factors influencing long-term response.Trail registration number NCT03529045.
