Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry. Issue 2 (23rd December 2021)

• Record Type: Journal Article
• Authors: Sen, Arjune; Verner, Ryan; Valeriano, James P; Lee, Ricky; Zafar, Muhammad; Thomas, Rhys; Kotulska, Katarzyna; Jespers, Ellen; Dibué, Maxine; Kwan, Patrick
• Other Names: author non-byline.; Riney Kate author non-byline.; Harvey Simon author non-byline.; Kwan Patrick author non-byline.; O'Brien Terry author non-byline.; Nagarajan Lakshmi author non-byline.; von Oertzen Tim author non-byline.; El Tahry Riem author non-byline.; Vonck Kristl author non-byline.; Julião deOliveira Andréa author non-byline.; D'Andrea Meira Isabella author non-byline.; Keezer Mark author non-byline.; Veilleux Martin author non-byline.; Myers Kenneth author non-byline.; Burneo Jorge author non-byline.; Andrade Andrea author non-byline.; Luan GuoMing author non-byline.; Li Fangcheng author non-byline.; Xu JiWen author non-byline.; Sarma Gosala Raja author non-byline.; Udani Vrajesh author non-byline.; Kurwale Nilesh author non-byline.; Tzadok Michal author non-byline.; Fahoum Firas author non-byline.; Goldberg-Stern Hadassa author non-byline.; Tinuper Paolo author non-byline.; Specchio Nicola author non-byline.; Shimada Seijiro author non-byline.; Ono Tomonori author non-byline.; Gunning Boudewijn author non-byline.; Wagner Louis author non-byline.; Neuteboom Rinze author non-byline.; Krzystanek Ewa author non-byline.; Kotulska Katarzyna author non-byline.; Al-Said Youssef author non-byline.; Alkhateeb Mashael Omar author non-byline.; Sieradzan Kasia author non-byline.; McCormick David author non-byline.; Thomas Rhys author non-byline.; Cochius Jeffrey author non-byline.; Reuber Markus author non-byline.; Keough Karen author non-byline.; Frost Marc author non-byline.; Collier Marie author non-byline.; Liow Kore author non-byline.; Lee Ricky author non-byline.; Boggs Jane author non-byline.; Sadek Ahmed author non-byline.; Wheless James author non-byline.; Morris George author non-byline.; Gelfand Michael author non-byline.; Bagic Anto author non-byline.; Valeriano James author non-byline.; Zafar Muhammad author non-byline.; Leary Linda author non-byline.; Zhou Xiangping author non-byline.; Ferreira Jose author non-byline.; Motamedi Gholam author non-byline.; Lyons Paul author non-byline.; Sen Arjune author non-byline.; Li Yongjie author non-byline.; Iwasaki Masaki author non-byline.;
• Is Part Of: BMJ neurology open. Volume 3:Issue 2(2021)
• Publication Date: 2021-12-23
• Subjects: epilepsy -- epilepsy -- surgery -- paediatric neurology -- paediatric neurosurgery; Neurology -- Periodicals; 616.8
• DOI: 10.1136/bmjno-2021-000218
• Languages: English
• ISSNs: 2632-6140

Abstract

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 .