Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

使用 Epilog 传感器进行自动癫痫发作检测，用于家庭癫痫发作监测

• 批准号: 10402377
• 负责人: Mark J. Lehmkuhle
• 金额: $ 99.31万
• 依托单位: EPITEL, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-15 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402377
• 关键词: Adoption; Algorithms; Applications Grants; Artificial Intelligence; Auras; Awareness; Back; Behavioral; Bluetooth; Businesses; Cellular Phone; Clinical; Community Hospitals; Consumption; Cues; Data; Data Collection; Data Set; Detection; Development; Diagnosis; Electroencephalography; Emergency Medicine; Environment; Environmental Risk Factor; Epilepsy; Event; Family; Financial Hardship; Focal Seizure; Forehead; Freedom; Goals; Gold; Home; Hospitals; Hour; Left; Life; Location; Machine Learning; Manuals; Medical Device; Methods; Modeling; Monitor; Morphologic artifacts; Motion; Neurologic; Paper; Patient Self-Report; Patients; Periodicity; Persons; Phase; Physiological; Precipitating Factors; Predisposition; Probability; Process; Quality of life; Reproducibility; Running; Scalp structure; Screening procedure; Secure; Seizures; Services; Sleep; Subclinical Seizures; System; Time; Validation; Work; base; cloud platform; cost; design; diaries; digital; digital health; effective therapy; encryption; improved; machine learning algorithm; motor impairment; multimodal data; multimodality; optimal treatments; programs; psychologic; remote monitoring; sensor; social; standard of care; wireless

ABSTRACT Aura is a digital health platform that uses Epilog™, a miniature, wireless, wearable EEG sensor worn on the scalp below hairline that can record clinical and subclinical seizures. After an initial diagnosis of epilepsy, an epileptologist will use known information about patients’ seizures to guide the best scalp location to place the Epilog EEG sensor (A). EEG data is continuously transferred (B) to the Aura app on a person’s smartphone (C) using secure BluetoothTM where it communicates over WiFi (D) to the Aura cloud platform (E). Epilog EEG is analyzed for seizures and a daily digital seizure diary is shared with epileptologists (F) and pushed back to the Aura app (G). Epilog is recharged daily, and reusable for a year. Epilog is designed to be discreet, allowing for continuous use in all facets of daily life. Data are a 10 s snippet of the beginning of a focal seizure with motor impairment and intact awareness (ILAE 1A1) recorded from Epitel’s single-channel Epilog sensor placed on the left forehead. The patient was admitted for video-EEG monitoring as standard-of-care. This seizure was verified independently by three epileptologists. In Phase I, automated, machine learning-based seizure detection algorithms will be designed to first work in the Aura cloud to detect seizures in Epilog EEG, including seizures a person may not consciously know they are having (>50% of all seizures), such as while sleeping. Aura will run these algorithms developed exclusively for Epilog’s single-channel of EEG to provide a daily digital seizure diary. In Phase II, the Aura system will enter clinical validation trials for FDA clearance as an EEG-based automated home seizure detection and alerting system. Early in Phase II Aura will be commercialized as a medical device-enabled-service business model. Out-of-pocket costs for a person living with epilepsy is an average of $380/year. Armed with long-term, reproducible EEG, epileptologists will now have a more precise, quantitative record of seizure counts, enabling them to adapt patient treatment more rapidly and successfully to improve quality of life. Aura will give people living with epilepsy their lives back. Aura provides certainty where you are and when you need it. Throughout Phase II, physiological, psychological, behavioral, and environmental factors will be combined in the Aura app to collect 27,000 days of multi-modal data from 300 patients to create an unprecedented dataset of features known to precipitate seizures. These data will be used in Phase III to create a robust, wearable seizure forecasting system using artificial intelligence that combines multi-modal seizure precipitating factors, creating an hourly seizure probability. Aura will profoundly disrupt how epilepsy is managed and improve the quality of life of people living with epilepsy.

摘要