Responsive Vagus Nerve Stimulation for Drug Resistant Epilepsy: A Review of New Features and Practical Guidance for Advanced Practice Providers

Fisher, Breanne; DesMarteau, Julie; Koontz, Elizabeth H.; Wilks, Seth J.; Melamed, Susan

doi:10.3389/fneur.2020.610379

Cited by 54 publications

(48 citation statements)

References 34 publications

(7 reference statements)

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“…The external programming system allows healthcare providers to change generator settings in addition to visualizing and downloading data collected by the device over time (3). A detailed review of the surgical implant procedure, magnetic resonance imaging safety and compatibility, programming principles, and real-world clinical evidence that supports the therapy's use can be found elsewhere (4)(5)(6)(7)(8)(9).…”

Section: Introductionmentioning

confidence: 99%

“…As of this review, over 125,000 patients have been implanted with the therapy worldwide (6). As new anti-epileptic neuromodulation device technologies enter the therapeutic space, the clinical utility of their programming features and stimulation capabilities must be considered in addition to seizure burden reduction in order to choose the most appropriate therapy for a patient (7)(8)(9)(32)(33)(34)(35)(36)(37).…”

Section: Introductionmentioning

confidence: 99%

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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: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

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.

View full text Add to dashboard Cite

show abstract

“…Baseline stimulation is the primary operating paradigm in which the device continually cycles with an intermittent stimulation active 24 h per day with on and off periods (e.g., 30 s on and 5 min off). Magnet mode stimulation allows the patient or caregiver to deliver adjunctive stimulation at the occurrence of a seizure, triggered by swiping a magnet over the pulse generator ( 122 ). Responsive VNS is a modern approach based on closed-loop auto-stimulation, which automatically delivers stimulation triggered by ictal tachycardia, a marker for seizure onset occurring in >80% of both generalized and focal seizures ( 119 , 122 ).…”

Section: Alternatives To Pharmacological Treatment In Drug-resistant Epilepsymentioning

confidence: 99%

“…Magnet mode stimulation allows the patient or caregiver to deliver adjunctive stimulation at the occurrence of a seizure, triggered by swiping a magnet over the pulse generator ( 122 ). Responsive VNS is a modern approach based on closed-loop auto-stimulation, which automatically delivers stimulation triggered by ictal tachycardia, a marker for seizure onset occurring in >80% of both generalized and focal seizures ( 119 , 122 ). Generally, it is recommended to start with baseline stimulation 2 weeks after device implantation.…”

Section: Alternatives To Pharmacological Treatment In Drug-resistant Epilepsymentioning

confidence: 99%

The Pharmacoresistant Epilepsy: An Overview on Existent and New Emerging Therapies

et al. 2021

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Epilepsy is one of the most common neurological chronic disorders, with an estimated prevalence of 0. 5 – 1%. Currently, treatment options for epilepsy are predominantly based on the administration of symptomatic therapy. Most patients are able to achieve seizure freedom by the first two appropriate drug trials. Thus, patients who cannot reach a satisfactory response after that are defined as pharmacoresistant. However, despite the availability of more than 20 antiseizure medications (ASMs), about one-third of epilepsies remain drug-resistant. The heterogeneity of seizures and epilepsies, the coexistence of comorbidities, and the broad spectrum of efficacy, safety, and tolerability related to the ASMs, make the management of these patients actually challenging. In this review, we analyze the most relevant clinical and pathogenetic issues related to drug-resistant epilepsy, and then we discuss the current evidence about the use of available ASMs and the alternative non-pharmacological approaches.

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“…Despite these temporal fluctuations, current FDA-approved DBS and responsive neurostimulation (RNS) devices for control of seizures run a fixed algorithm regardless of the time. Vagal nerve stimulators do enable two settings for implementing diurnal control, which show promise for managing side-effects and correlating therapy with symptoms (Fisher et al, 2021). Similarly, disrupted sleep-wake cycles are a common co-morbidity of PD, depression and epilepsy, but current DBS devices default to fixed, tonic stimulation parameters that are configured based on an assessment of efficacy during a daytime follow-up (Malhotra, 2018).…”

Section: Introductionmentioning

confidence: 99%

Case Report: Embedding “Digital Chronotherapy” Into Medical Devices—A Canine Validation for Controlling Status Epilepticus Through Multi-Scale Rhythmic Brain Stimulation

et al. 2021

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Circadian and other physiological rhythms play a key role in both normal homeostasis and disease processes. Such is the case of circadian and infradian seizure patterns observed in epilepsy. However, these rhythms are not fully exploited in the design of active implantable medical devices. In this paper we explore a new implantable stimulator that implements chronotherapy as a feedforward input to supplement both open-loop and closed-loop methods. This integrated algorithm allows for stimulation to be adjusted to the ultradian, circadian and infradian patterns observed in patients through slowly-varying temporal adjustments of stimulation and algorithm sub-components, while also enabling adaption of stimulation based on immediate physiological needs such as a breakthrough seizure or change of posture. Embedded physiological sensors in the stimulator can be used to refine the baseline stimulation circadian pattern as a “digital zeitgeber,” i.e., a source of stimulus that entrains or synchronizes the subject's natural rhythms. This algorithmic approach is tested on a canine with severe drug-resistant idiopathic generalized epilepsy exhibiting a characteristic diurnal pattern correlated with sleep-wake cycles. Prior to implantation, the canine's cluster seizures evolved to status epilepticus (SE) and required emergency pharmacological intervention. The cranially-mounted system was fully-implanted bilaterally into the centromedian nucleus of the thalamus. Using combinations of time-based modulation, thalamocortical rhythm-specific tuning of frequency parameters as well as fast-adaptive modes based on activity, the canine experienced no further SE events post-implant as of the time of writing (7 months). Importantly, no significant cluster seizures have been observed either, allowing the reduction of rescue medication. The use of digitally-enabled chronotherapy as a feedforward signal to augment adaptive neurostimulators could prove a useful algorithmic method in conditions where sensitivity to temporal patterns are characteristics of the disease state, providing a novel mechanism for tailoring a more patient-specific therapy approach.

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Responsive Vagus Nerve Stimulation for Drug Resistant Epilepsy: A Review of New Features and Practical Guidance for Advanced Practice Providers

Cited by 54 publications

References 34 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

The Pharmacoresistant Epilepsy: An Overview on Existent and New Emerging Therapies

Case Report: Embedding “Digital Chronotherapy” Into Medical Devices—A Canine Validation for Controlling Status Epilepticus Through Multi-Scale Rhythmic Brain Stimulation

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