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

Abstract

IntroductionThe 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 analysisThe 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 disseminationThe 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 numberNCT03529045.

Anesthesia management in patients with neurostimulators

“…8,10 Vagal nerve stimulation (VNS) VNS was first approved for the management of drug-resistant epilepsy (DRE) in Europe in 1994. 11 In addition, VNS has been approved by the FDA in 2005 for the treatment of severe, recurrent unipolar, and bipolar depression in the United States. 12 A VNS system consists of a rubber-imbedded platinum electrode wrapped around the left vagus nerve and an IPG placed subcutaneously in the infraclavicular area.…”

“…VNS was first approved for the management of drug-resistant epilepsy (DRE) in Europe in 1994 11 . In addition, VNS has been approved by the FDA in 2005 for the treatment of severe, recurrent unipolar, and bipolar depression in the United States 12 .…”

The Neuromodulator Effect of Vagal Nerve Stimulation as the Treatment of Medically Refractory Epilepsy in Comparison with Surgical Approach: A Systematic Review

“…They documented a 28% reduction in seizures with high stimulation versus a 15% reduction with sham stimulation, with 23% of individuals in the therapeutic group attaining ≥ 50% reduction in attacks at three months after surgery. Finally, Amar and colleagues reported more dramatic results in a smaller VNS trial of 17 individuals, with 57% of treated patients attaining ≥ 50% decrease in seizures [8]. We identified two nonblinded, randomized controlled trials (Class II evidence) byTzadok et al and Muthiah et al, who studied the response of 28 and 61 patients, respectively, to various VNS stimulation paradigms.…”