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Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit

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dc.creator Onorati, Francesco
dc.creator Regalia, Giulia
dc.creator Caborni, Chiara
dc.creator LaFrance, W Curt
dc.creator Blum, Andrew S
dc.creator Bidwell, Jonathan
dc.creator De Liso, Paola
dc.creator El Atrache, Rima
dc.creator Loddenkemper, Tobias
dc.creator Mohammadpour-Touserkani, Fatemeh
dc.creator Sarkis, Rani A
dc.creator Friedman, Daniel
dc.creator Jeschke, Jay
dc.creator Picard, Rosalind
dc.date 2022-11-22T19:16:15Z
dc.date 2022-11-22T19:16:15Z
dc.date 2021
dc.date 2022-11-22T19:09:39Z
dc.date.accessioned 2023-02-17T20:14:31Z
dc.date.available 2023-02-17T20:14:31Z
dc.identifier https://hdl.handle.net/1721.1/146599
dc.identifier Onorati, Francesco, Regalia, Giulia, Caborni, Chiara, LaFrance, W Curt, Blum, Andrew S et al. 2021. "Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit." Frontiers in Neurology, 12.
dc.identifier.uri http://localhost:8080/xmlui/handle/CUHPOERS/242273
dc.description <jats:p><jats:bold>Background:</jats:bold> Using machine learning to combine wrist accelerometer (ACM) and electrodermal activity (EDA) has been shown effective to detect primarily and secondarily generalized tonic-clonic seizures, here termed as convulsive seizures (CS). A prospective study was conducted for the FDA clearance of an ACM and EDA-based CS-detection device based on a predefined machine learning algorithm. Here we present its performance on pediatric and adult patients in epilepsy monitoring units (EMUs).</jats:p><jats:p><jats:bold>Methods:</jats:bold> Patients diagnosed with epilepsy participated in a prospective multi-center clinical study. Three board-certified neurologists independently labeled CS from video-EEG. The Detection Algorithm was evaluated in terms of Sensitivity and false alarm rate per 24 h-worn (FAR) on all the data and on only periods of rest. Performance were analyzed also applying the Detection Algorithm offline, with a less sensitive but more specific parameters configuration (“Active mode”).</jats:p><jats:p><jats:bold>Results:</jats:bold> Data from 152 patients (429 days) were used for performance evaluation (85 pediatric aged 6–20 years, and 67 adult aged 21–63 years). Thirty-six patients (18 pediatric) experienced a total of 66 CS (35 pediatric). The Sensitivity (corrected for clustered data) was 0.92, with a 95% confidence interval (CI) of [0.85-1.00] for the pediatric population, not significantly different (<jats:italic>p</jats:italic> &amp;gt; 0.05) from the adult population's Sensitivity (0.94, CI: [0.89–1.00]). The FAR on the pediatric population was 1.26 (CI: [0.87–1.73]), higher (<jats:italic>p</jats:italic> &amp;lt; 0.001) than in the adult population (0.57, CI: [0.36–0.81]). Using the Active mode, the FAR decreased by 68% while reducing Sensitivity to 0.95 across the population. During rest periods, the FAR's were 0 for all patients, lower than during activity periods (<jats:italic>p</jats:italic> &amp;lt; 0.001).</jats:p><jats:p><jats:bold>Conclusions:</jats:bold> Performance complies with FDA's requirements of a lower bound of CI for Sensitivity higher than 0.7 and of a FAR lower than 2, for both age groups. The pediatric FAR was higher than the adult FAR, likely due to higher pediatric activity. The high Sensitivity and precision (having no false alarms) during sleep might help mitigate SUDEP risk by summoning caregiver intervention. The Active mode may be advantageous for some patients, reducing the impact of the FAR on daily life. Future work will examine the performance and usability outside of EMUs.</jats:p>
dc.format application/pdf
dc.language en
dc.publisher Frontiers Media SA
dc.relation 10.3389/FNEUR.2021.724904
dc.relation Frontiers in Neurology
dc.rights Creative Commons Attribution 4.0 International license
dc.rights https://creativecommons.org/licenses/by/4.0/
dc.source Frontiers
dc.title Prospective Study of a Multimodal Convulsive Seizure Detection Wearable System on Pediatric and Adult Patients in the Epilepsy Monitoring Unit
dc.type Article
dc.type http://purl.org/eprint/type/JournalArticle


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