Comparison of seizure control outcomes and the safety of vagus nerve, thalamic deep brain, and responsive neurostimulation: evidence from randomized controlled trials

Rolston, John D.; Englot, Dario J.; Wang, Doris D.; Shih, Tina; Chang, Edward F.

doi:10.3171/2012.1.focus11335

Cited by 48 publications

(33 citation statements)

References 29 publications

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“…Complete freedom from seizures is significantly more likely with resective or ablative epilepsy surgery, reported in 50-80% of surgical cases [31], than with VNS, observed in approximately 8% of patients after > 24 months of therapy [19]. With VNS, approximately 50-60% of epilepsy patients achieve ≥ 50% reduction in seizure frequency after 12-24 months of treatment [16], and similar seizure outcomes have been reported with other neurostimulation therapies for epilepsy [13]. Thus, seizure freedom must be the ultimate goal in epilepsy treatment whenever possible, but VNS and other neuromodulation-based treatments represent additional treatment options for patients who are not candidates for or who refuse resection or ablation.…”

Section: Discussionmentioning

confidence: 85%

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Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data

Englot

Hassnain

Rolston

et al. 2017

Epilepsy & Behavior

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Objective Drug-resistant epilepsy is a devastating disorder associated with diminished quality of life (QOL). Surgical resection leads to seizure freedom and improved QOL in many epilepsy patients, but not all individuals are candidates for resection. In these cases, neuromodulation-based therapies such as vagus nerve stimulation (VNS) are often used, but most VNS studies focus exclusively on reduction of seizure frequency. QOL changes and predictors with VNS remain poorly understood. Method Using the VNS Therapy Patient Outcome Registry, we examined 7 metrics related to QOL after VNS for epilepsy in over 5,000 patients (including over 3,000 with ≥ 12 months follow-up), as subjectively assessed by treating physicians. Trends and predictors of QOL changes were examined and related to post-operative seizure outcome and likelihood of VNS generator replacement. Results After VNS therapy, physicians reported patient improvement in alertness (58-63%, range over follow-up period), post-ictal state (55-62%), cluster seizures (48-56%), mood change (43-49%), verbal communication (38-45%), school/professional achievements (29-39%), and memory (29-38%). Predictors of net QOL improvement included shorter time to implant (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.1-1.6), generalized seizure type (OR, 1.2; 95% CI, 1.0-1.4), female gender (OR, 1.2; 95% CI, 1.0-1.4), and Caucasian ethnicity (OR, 1.3; 95% CI, 1.0-1.5). No significant trends were observed over time. Patients with net QOL improvement were more likely to have favorable seizure outcomes (chi square [χ2] = 148.1, p < 0.001) and more likely to undergo VNS generator replacement (χ2 = 68.9, p < 0.001) than those with worsened/unchanged QOL. Significance VNS for drug-resistant epilepsy is associated with improvement on various QOL metrics subjectively rated by physicians. QOL improvement is associated with favorable seizure outcome and a higher likelihood of generator replacement, suggesting satisfaction with therapy. It is important to consider QOL metrics in neuromodulation for epilepsy, given the deleterious effects of seizures on patient QOL.

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Section: Discussionmentioning

confidence: 85%

“…In these individuals, neuromodulation-based surgical therapies are often considered, of which vagus nerve stimulation (VNS) is the most common [13]. These palliative neurostimulation therapies often result in reduced seizure frequency, although seizure freedom is significantly less common than with resection [14].…”

Section: Introductionmentioning

confidence: 99%

Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data

Englot

Hassnain

Rolston

et al. 2017

Epilepsy & Behavior

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“…Results from the key randomized clinical trials published to date for DBS, eTNS, RNS, and VNS show that the responder rate for each of these devices ranges from 23% to 30% for the acute double-blind trial period, and 35% to 43% at 1 year. 32 These long-term responder rates reveal that the efficacy of neurostimulation generally tends to increase over time, which may be a function of long-term inhibition or potentiation of the key neural networks involved.…”

Section: Discussionmentioning

confidence: 98%

Neurostimulation for Drug-Resistant Epilepsy

DeGiorgio

Krahl²

2013

CONTINUUM: Lifelong Learning in Neurology

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Purpose of Review: The purpose of this review is to provide an evidence-based update on the neurostimulation options available for patients with drug-resistant epilepsy in the United States and in European countries. Recent Findings: The field of neurostimulation for epilepsy has grown dramatically since 1997, when vagus nerve stimulation became the first device to be approved for epilepsy by the US Food and Drug Administration (FDA). New data from recently completed randomized controlled trials are available for deep brain stimulation of the anterior thalamus, responsive neurostimulation, and trigeminal nerve stimulation. Although vagus nerve stimulation is the only device currently approved in the United States, deep brain stimulation and responsive neurostimulation devices are awaiting FDA approval. Deep brain stimulation, trigeminal nerve stimulation, and transcutaneous vagus nerve stimulation are now approved for epilepsy in the European Union. In this article, the mechanisms of action, safety, and efficacy of new neurostimulation devices are reviewed, and the key advantages and disadvantages of each are discussed. Summary: The exponential growth of the field of neuromodulation for epilepsy is an exciting development; these new devices provide physicians with new options for patients with drug-resistant epilepsy.

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“…In DBS for epilepsy, recent focus has turned to the anterior nucleus of the thalamus, a structure in the classic circuit of Papez intimately connected to limbic structures, and with widespread neocortical projections [106]. Thalamic DBS has been approved as adjunctive treatment for medication-resistant epilepsy as well as secondary generalized seizures in Canada, the European Union, Australia, Taiwan, New Zealand, and Australia, but it is not yet approved by the US FDA [8,53].…”

Section: Neurostimulation Proceduresmentioning

confidence: 99%

“…While VNS and DBS use open-loop stimulation paradigms with uninterrupted electrical pulses, RNS utilizes a closed-loop stimulation system [106]. Implanted subdural and depth electrodes continuously record neurophysiological signals during ictal events, and these data can be analyzed offline for programming of the device.…”

Section: Neurostimulation Proceduresmentioning

confidence: 99%

Seizure outcomes in nonresective epilepsy surgery: an update

2016

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In approximately 30% of patients with epilepsy, seizures are refractory to medical therapy, leading to significant morbidity and increased mortality. Substantial evidence has demonstrated the benefit of surgical resection in patients with drug-resistant focal epilepsy, and in the present journal, we recently reviewed seizure outcomes in resective epilepsy surgery. However, not all patients are candidates for or amenable to open surgical resection for epilepsy. Fortunately, several non-resective surgical options are now available at various epilepsy centers, including novel therapies which have been pioneered in recent years. Ablative procedures such as stereotactic laser ablation and stereotactic radiosurgery offer minimally invasive alternatives to open surgery with relatively favorable seizure outcomes, particularly in patients with mesial temporal lobe epilepsy. For certain individuals who are not candidates for ablation or resection, palliative neuromodulation procedures such as vagus nerve stimulation, deep brain stimulation, or responsive neurostimulation may result in a significant decrease in seizure frequency and improved quality of life. Finally, disconnection procedures such as multiple subpial transections and corpus callosotomy continue to play a role in select patients with an eloquent epileptogenic zone or intractable atonic seizures, respectively. Overall, open surgical resection remains the gold standard treatment for drug-resistant epilepsy, although it is significantly under-utilized. While non-resective epilepsy procedures have not replaced the need for resection, there is hope that these additional surgical options will increase the number of patients who receive treatment for this devastating disorder - particularly individuals who are not candidates for or who have failed resection.

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Comparison of seizure control outcomes and the safety of vagus nerve, thalamic deep brain, and responsive neurostimulation: evidence from randomized controlled trials

Cited by 48 publications

References 29 publications

Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data

Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data

Neurostimulation for Drug-Resistant Epilepsy

Seizure outcomes in nonresective epilepsy surgery: an update

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