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

2021 ◽  
Vol 3 (2) ◽  
pp. e000218
Author(s):  
Arjune Sen ◽  
Ryan Verner ◽  
James P Valeriano ◽  
Ricky Lee ◽  
Muhammad Zafar ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Real World ◽  
Vagus Nerve Stimulation ◽  
Drug Resistant ◽  
The Core ◽  
Post Market ◽  
Drug Resistant Epilepsy

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.

scholarly journals Effect of Long-Term Treatment with Vagus Nerve Stimulation on Mood and Quality of Life in Korean Patients with Drug-Resistant Epilepsy

2021 ◽  
Vol 17 (3) ◽  
pp. 385
Author(s):  
Jeong Sik Kim ◽  
Dong Yeop Kim ◽  
Hyun Jin Jo ◽  
Yoon Ha Hwang ◽  
Joo Yeon Song ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Term Treatment ◽  
Drug Resistant ◽  
Long Term Treatment ◽  
Drug Resistant Epilepsy

Vagus nerve stimulation for drug-resistant epilepsy

2019 ◽  
Vol 20 (3) ◽  
pp. 189-198 ◽  
Author(s):  
Laura Pérez-Carbonell ◽  
Howard Faulkner ◽  
Sean Higgins ◽  
Michalis Koutroumanidis ◽  
Guy Leschziner
Keyword(s):  
Vagus Nerve ◽  
Seizure Frequency ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Therapeutic Option ◽  
Drug Resistant ◽  
Drug Resistant Epilepsy ◽  
Randomised Controlled

Vagus nerve stimulation (VNS) is a neuromodulatory therapeutic option for drug-resistant epilepsy. In randomised controlled trials, VNS implantation has resulted in over 50% reduction in seizure frequency in 26%–40% of patients within 1 year. Long-term uncontrolled studies suggest better responses to VNS over time; however, the assessment of other potential predictive factors has led to contradictory results. Although initially designed for managing focal seizures, its use has been extended to other forms of drug-resistant epilepsy. In this review, we discuss the evidence supporting the use of VNS, its impact on seizure frequency and quality of life, and common adverse effects of this therapy. We also include practical guidance for the approach to and the management of patients with VNS in situ.

Long-term results of vagus nerve stimulation in children and adolescents with drug-resistant epilepsy

2012 ◽  
Vol 28 (4) ◽  
pp. 621-628 ◽  
Author(s):  
Beata Majkowska-Zwolińska ◽  
Piotr Zwoliński ◽  
Marcin Roszkowski ◽  
Krzysztof Drabik
Keyword(s):  
Vagus Nerve ◽  
Children And Adolescents ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Long Term Results ◽  
Drug Resistant ◽  
Drug Resistant Epilepsy

scholarly journals Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Allan H. Young ◽  
Mario F. Juruena ◽  
Renske De Zwaef ◽  
Koen Demyttenaere
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Real World ◽  
Patient Population ◽  
Vagus Nerve Stimulation ◽  
Rating Scale ◽  
Symptom Control ◽  
Study Results ◽  
Post Market

Abstract Background Depressive illness is associated with significant adverse consequences for patients and their families, and for society. Clinical challenges are encountered in the management of patients suffering from depression whether they are designated difficult-to-treat or treatment-resistant. Prospective serial depression treatment trials have shown that less than 40% of patients with major depressive disorder remit with an initial pharmacotherapy trial, and a progressively smaller proportion of patients remit with each subsequent trial. For patients who suffer from difficult-to-treat depression (DTD), treatments should focus on patient-centred symptom control, patient functioning, and improving patient quality of life. Among the treatment options for patients with DTD is Vagus Nerve Stimulation (VNS) Therapy. VNS Therapy involves intermittent electrical stimulation of the left cervical vagus nerve and has been shown to be efficacious for long-term management of patients with DTD. Methods RESTORE-LIFE is a prospective, observational, multi-site, global post-market study intended to assess short-, mid-, and long-term effectiveness and efficiency outcomes in a ‘real-world’ setting among patients with DTD treated with adjunctive VNS Therapy. A minimum of 500 patients will be implanted with a VNS Therapy System at up to 80 global sites. Eligible patients will participate in a baseline visit between 1 and 6 weeks before device implant and will be followed for a minimum of 36 months and a maximum of 60 months. The diagnosis of depression and comorbid disorders will be determined using the Mini-International Neuropsychiatric Interview (MINI). The primary endpoint is response rate, defined as a decrease of ≥50% in Montgomery Åsberg Depression Rating Scale (MADRS) total score from baseline to 12 months post-implant. Discussion A standardized approach in the management of DTD may not be appropriate for the treatment of such a complex heterogenous patient population. This study has been designed to evaluate whether VNS Therapy meaningfully improves and sustains clinical and depressive symptom outcomes in patients with DTD. This study will investigate the durability of VNS response in DTD and utility of VNS for long-term disease management of DTD. In addition, the study results will potentially clarify clinical, functional, and health economic questions in a real-world patient population with DTD. Trial registration ClinicalTrials.gov NCT03320304. Registered 25 October 2017

Vagus nerve stimulation for drug-resistant epilepsy: A European long-term study up to 24 months in 347 children

Epilepsia ◽  
2014 ◽  
Vol 55 (10) ◽  
pp. 1576-1584 ◽  
Author(s):  
Iren Orosz ◽  
David McCormick ◽  
Nelia Zamponi ◽  
Sophia Varadkar ◽  
Martha Feucht ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Drug Resistant ◽  
Term Study ◽  
Long Term Study ◽  
Drug Resistant Epilepsy

scholarly journals Case Report: 1-Year Follow-Up of Vagus Nerve Stimulation in a Dog With Drug-Resistant Epilepsy

2021 ◽  
Vol 8 ◽  
Author(s):  
Junya Hirashima ◽  
Miyoko Saito ◽  
Hirotaka Igarashi ◽  
Satoshi Takagi ◽  
Daisuke Hasegawa
Keyword(s):  
Adverse Effects ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Drug Resistant ◽  
Stimulation Parameters ◽  
Term Evaluation ◽  
Drug Resistant Epilepsy

A vagus nerve stimulation (VNS) system was surgically implanted to treat drug-resistant epilepsy in a 5-year-old male Shetland Sheepdog. At regular visits during a 1-year follow-up, treatment efficacy and adverse effects were assessed, and programmable stimulation parameters were adjusted to optimize stimulation intensity while avoiding adverse effects. The frequency of generalized tonic–clonic seizures was reduced by 87% after the initiation of VNS. The owner reported that the dog regained his personality, and the quality of life of both the dog and owner improved. The only adverse effect of VNS was a cough that was controlled by adjusting stimulation parameters. There were no surgical complications or other issues with the VNS device. This is the first long-term evaluation of VNS therapy in a dog, and the results obtained suggest that gradual adjustments of VNS parameters facilitate optimum VNS dosing.

scholarly journals Is vagus nerve stimulation effective in the treatment of drug-resistant epilepsy?

2018 ◽  
Vol 1 (4) ◽  
pp. 219-221
Author(s):  
Ann Mertens ◽  
Paul Boon ◽  
Kristl Vonck
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Drug Resistant ◽  
Drug Resistant Epilepsy
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