Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study

Cook, Mark; O’Brien, Terence J.; Berkovic, Samuel F.; Murphy, Michael A.; Morokoff, Andrew; Fabinyi, Gavin; D’Souza, Wendyl; Yerra, Raju; Archer, John S.; Litewka, Lucas; Hosking, Sean; Lightfoot, Paul A.; Ruedebusch, Vanessa; Sheffield, W. Douglas; Snyder, David; Leyde, Kent; Himes, David

doi:10.1016/s1474-4422(13)70075-9

Cited by 735 publications

(797 citation statements)

References 37 publications

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“…Copyright Ó 2013 Elsevier Ltd. Reprinted from (Cook O'Brien Berkovic et al 2013) Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: A first-in-man study. The Lancet Neurology.…”

Section: Methodsmentioning

confidence: 99%

Embodiment and Estrangement: Results from a First-in-Human “Intelligent BCI” Trial

et al. 2017

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While new generations of implantable brain computer interface (BCI) devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent-predictive and advisory-BCI technologies essential to prevent potential iatrogenic harms.

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Section: Methodsmentioning

confidence: 99%

Embodiment and Estrangement: Results from a First-in-Human “Intelligent BCI” Trial

et al. 2017

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“…Third, unanticipated toxicities in humans may preclude reaching the effective drug levels. Fourth, compliance may be variable in humans and seizure reporting in humans may not be as accurate if it depends on patient or family reports rather than the usual video‐EEG studies done in animals 68. Fifth, control groups in preclinical and clinical studies may be quite different.…”

Section: Opportunities To Narrow the Preclinical‐clinical Trial Gap Amentioning

confidence: 99%

Not all that glitters is gold: A guide to critical appraisal of animal drug trials in epilepsy

Galanopoulou

Mowrey

2016

Epilepsia Open

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SummaryPreclinical studies have produced numerous drugs with antiseizure properties that currently are the standard of care. One third of the human population with epilepsy still continues to have seizures despite the ongoing discoveries. The recognized clinical gaps of care that need to be addressed are the identification of antiepileptogenic and disease‐modifying treatments, and treatments for refractory seizures or for seizures and epilepsies with limited or unsatisfactory treatments, such as early life epileptic encephalopathies. In this invited review, we provide a historical summary of the international efforts to reevaluate the strategies adopted in preclinical epilepsy therapy discovery studies. We discuss issues that may affect the quality, interpretation, and validation of preclinical studies and their translation to successful therapies for humans affected with epilepsy. These include the selection of animal models and the study design; research practices that affect rigor (such as appropriate use of statistics and reporting of study methods and results, their validation across models, labs, and preclinical‐clinical studies); the need to harmonize research methods and outcome assessment; and the importance of improving translation to clinically appropriate situations. The epilepsy research community is incrementally adopting collaborative research, including consortia or multicenter studies to meet these needs. Improving the infrastructure that can support these efforts will be instrumental in future success.

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“…In a study by Bonn in which the patients’ diaries were compared to video electroencephalogram (EEG) telemetry, patients recorded only 44% of partial seizures, and even major seizures were missed, as were four out of five seizures at night 6. In a study using long‐term intracranial monitoring, 8 out of the 11 patients studied underestimated the real seizure rate by at least threefold 7. One patient, who had 126 seizures recorded per month, considered none to have occurred, and another recorded a monthly seizure rate of 11 per month when in fact the true figure was 102 per month.…”

Section: Today's Theories and Practices Which May Not Withstand The Tmentioning

confidence: 99%

The right and the wrong with epilepsy and her science

Shorvon

Schmidt²

2016

Epilepsia Open

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SummaryThis is a commentary and an opinion paper attempting a critical reassessment of the methods and practices of epilepsy research as we see it. The enormous progress in the field of epilepsy in recent years is a cause of celebration. Advances have been made on most fronts, and the position of patients with epilepsy in society has greatly improved. However, there have also been culs‐de‐sac and dead ends of modern science and clinical practice which are also intriguing. It may be true that we can learn more from our mistakes than from our successes. In this opinion paper, we have listed some of the successes and some of the failures of past epilepsy practice, and also areas of current practice and theory which we feel are likely to prove mistaken. The underlying reasons for misdirected practices and theories include, in our view, the influence of fashion, bad science, and the bureaucracies of practice and academic medicine. As a result, some findings are far from objective. Recognition is the first step to remediation, and hopefully future research will minimize some of the pitfalls mentioned in this article and bring the “End of Epilepsy,” as defined and predicted by Oswei Temkin, closer than it is today.

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Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study

Cited by 735 publications

References 37 publications

Embodiment and Estrangement: Results from a First-in-Human “Intelligent BCI” Trial

Embodiment and Estrangement: Results from a First-in-Human “Intelligent BCI” Trial

Not all that glitters is gold: A guide to critical appraisal of animal drug trials in epilepsy

The right and the wrong with epilepsy and her science

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