Impact of Cardiac-Based Vagus Nerve Stimulation Closed-Loop Stimulation on the Seizure Outcome of Patients With Generalized Epilepsy: A Prospective, Individual-Control Study

Cukiert, Arthur; Cukiert, Cristine Mella; Mariani, Pedro Paulo; Burattini, José Augusto

doi:10.1111/ner.13290

Cited by 9 publications

(3 citation statements)

References 18 publications

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“…The latest SenTiva R M1000 generator preserves the closedloop AutoStim Mode feature from the M106 generator release but resorted back to the smaller canister specifications of the M103 generator (3) (Table 1). Real-world use of the AutoStim Mode has been shown to increase VNS Therapy therapeutic efficacy in both pediatric and adult patients across varying epilepsy etiologies (50)(51)(52)(53)(54)(55). Additionally, patients who elect to switch from a conventional VNS Therapy generator to a closedloop AutoStim generator (e.g., M106, M1000, M1000-D) can experience additional therapeutic improvement upon generator replacement (50,52,56,57) (Table 2; Figure 1).…”

Section: Evolution Of the Vns Therapy Technologymentioning

confidence: 99%

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Afra

Adamolekun

Aydemir

et al. 2021

Front. Med. Technol.

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The vagus nerve stimulation (VNS) Therapy® System is the first FDA-approved medical device therapy for the treatment of drug-resistant epilepsy. Over the past two decades, the technology has evolved through multiple iterations resulting in software-related updates and implantable lead and generator hardware improvements. Healthcare providers today commonly encounter a range of single- and dual-pin generators (models 100, 101, 102, 102R, 103, 104, 105, 106, 1000) and related programming systems (models 250, 3000), all of which have their own subtle, but practical differences. It can therefore be a daunting task to go through the manuals of these implant models for comparison, some of which are not readily available. In this review, we highlight the technological evolution of the VNS Therapy System with respect to device approval milestones and provide a comparison of conventional open-loop vs. the latest closed-loop generator models. Battery longevity projections and an in-depth examination of stimulation mode interactions are also presented to further differentiate amongst generator models.

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Section: Evolution Of the Vns Therapy Technologymentioning

confidence: 99%

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Afra

Adamolekun

Aydemir

et al. 2021

Front. Med. Technol.

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show abstract

“…Responder rates ranged from 20 and 71% when comparing new responders transitioning from open-loop to closed-loop VNS (Hamilton et al 2018 ; Cukiert et al 2021 ). Closed-loop neuromodulation is a clinically effective treatment modality.…”

Section: Vns For Treating Epilepsymentioning

confidence: 99%

Importance of timing optimization for closed-loop applications of vagus nerve stimulation

et al. 2023

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In recent decades, vagus nerve stimulation (VNS) therapy has become widely used for clinical applications including epilepsy, depression, and enhancing the effects of rehabilitation. However, several questions remain regarding optimization of this therapy to maximize clinical outcomes. Although stimulation parameters such as pulse width, amplitude, and frequency are well studied, the timing of stimulation delivery both acutely (with respect to disease events) and chronically (over the timeline of a disease’s progression) has generally received less attention. Leveraging such information would provide a framework for the implementation of next generation closed-loop VNS therapies. In this mini-review, we summarize a number of VNS therapies and discuss (1) general timing considerations for these applications and (2) open questions that could lead to further therapy optimization.

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“…Of these new features, responsive VNS has been the most extensively studied, both in manufacturersponsored approval trials as well as in a series of independent prospective and retrospective single-centre cohort studies. [8][9][10][11][12][13][14][15][16][17][18][19] These initial investigations suggest that responsive VNS Therapy offers incremental benefit over traditional, non-responsive VNS and may be associated with an earlier onset of effect.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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Impact of Cardiac-Based Vagus Nerve Stimulation Closed-Loop Stimulation on the Seizure Outcome of Patients With Generalized Epilepsy: A Prospective, Individual-Control Study

Cited by 9 publications

References 18 publications

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy

Importance of timing optimization for closed-loop applications of vagus nerve stimulation

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

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