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Wearable devices for seizure detection: Practical experiences and recommendations from the Wearables for Epilepsy And Research (WEAR) International Study Group

Research output: Contribution to journalArticlepeer-review

Elisa Bruno, Sebastian Böttcher, Pedro F. Viana, Marta Amengual-Gual, Boney Joseph, Nino Epitashvili, Matthias Dümpelmann, Martin Glasstetter, Andrea Biondi, Kristof Van Laerhoven, Tobias Loddenkemper, Mark P. Richardson, Andreas Schulze-Bonhage, Benjamin H. Brinkmann

Original languageEnglish
Pages (from-to)2307-2321
Number of pages15
JournalEpilepsia
Volume62
Issue number10
Early online date22 Aug 2021
DOIs
Accepted/In press2021
E-pub ahead of print22 Aug 2021
PublishedOct 2021

Bibliographical note

Funding Information: The Remote Assessment of Disease and Relapse – Central Nervous System (RADAR‐CNS) project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 115902. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA), www.imi.europa.eu . This communication reflects the views of the RADAR‐CNS consortium and neither IMI nor the European Union and EFPIA is liable for any use that may be made of the information contained herein. TL and MAG were supported by the Epilepsy Research Fund. BHB and BJ were supported by the Epilepsy Foundation of America’s Epilepsy Innovation Institute, My Seizure Gauge project. Funding Information: The Remote Assessment of Disease and Relapse ? Central Nervous System (RADAR-CNS) project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 115902. This Joint Undertaking receives support from the European Union?s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA), www.imi.europa.eu. This communication reflects the views of the RADAR-CNS consortium and neither IMI nor the European Union and EFPIA is liable for any use that may be made of the information contained herein. TL and MAG were supported by the Epilepsy Research Fund. BHB and BJ were supported by the Epilepsy Foundation of America?s Epilepsy Innovation Institute, My Seizure Gauge project. Funding Information: MR is supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the South London and Maudsley Hospital; and the Medical Research Council (MRC) Centre for Neurodevelopmental Disorders (MR/N026063/1). TL serves on the Council and as Past President of the American Clinical Neurophysiology Society, as founder and consortium principal investigator (PI) of the pediatric status epilepticus research group (pSERG), as an Associate Editor for Wyllie's Treatment of Epilepsy 6th edition and 7th editions, and as a member of the New Onset Refractory Status Epilepticus (NORSE) Institute, and Critical Care EEG Monitoring Research Consortium (CCEMRC). He served as Associate Editor of , and served on the Laboratory Accreditation Board for Long Term (Epilepsy and Intensive Care Unit) Monitoring in the past. He is part of patent applications to detect and predict clinical outcomes, and to detect, manage, diagnose, and treat neurological conditions, epilepsy, and seizures. TL is co‐inventor of the TriVox Health technology, and TL and Boston Children's Hospital might receive financial benefits from this technology in the form of compensation in the future. He received research support from the Epilepsy Research Fund, National Institutes of Health (NIH), the Epilepsy Foundation of America, the Epilepsy Therapy Project, and the Pediatric Epilepsy Research Foundation, and he received research grants from Lundbeck, Eisai, Upsher‐Smith, Mallinckrodt, Sunovion, Sage, Empatica, and Pfizer, including past device donations from various companies, including Empatica, SmartWatch, and Neuro‐electrics. He served as a consultant for Zogenix, Upsher Smith, Amzell, Engage, Elsevier, UCB, Grand Rounds, Advance Medical, and Sunovion. He performs video electroencephalography long‐term and intensive care unit (ICU) monitoring, electroencephalography, and other electrophysiological studies at Boston Children's Hospital and affiliated hospitals and bills for these procedures, and he evaluates pediatric neurology patients and bills for clinical care. He has received speaker honorariums/travel support from national societies including the American Academy of Neurology (AAN), American Epilepsy Society (AES), and American Clinical Neurophysiology Society (ACNS), and for grand rounds at various academic centers. His wife is a pediatric neurologist and she performs video electroencephalography long‐term and ICU monitoring, electroencephalography, and other electrophysiological studies and she bills for these procedures, and she evaluates pediatric neurology patients and bills for clinical care. BHB has received non‐financial research support from Medtronic Inc. (devices for a trial) and has licensed intellectual property (IP) and equity in Cadence Neurosciences. MAG was funded by Fundación Alfonso Martín Escudero (2018–2019). The remaining authors have no conflicts of interest. Seizure Publisher Copyright: © 2021 International League Against Epilepsy

King's Authors

Abstract

The Wearables for Epilepsy And Research (WEAR) International Study Group identified a set of methodology standards to guide research on wearable devices for seizure detection. We formed an international consortium of experts from clinical research, engineering, computer science, and data analytics at the beginning of 2020. The study protocols and practical experience acquired during the development of wearable research studies were discussed and analyzed during bi-weekly virtual meetings to highlight commonalities, strengths, and weaknesses, and to formulate recommendations. Seven major essential components of the experimental design were identified, and recommendations were formulated about: (1) description of study aims, (2) policies and agreements, (3) study population, (4) data collection and technical infrastructure, (5) devices, (6) reporting results, and (7) data sharing. Introducing a framework of methodology standards promotes optimal, accurate, and consistent data collection. It also guarantees that studies are generalizable and comparable, and that results can be replicated, validated, and shared.

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