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: 10200346
• 负责人: Mark J. Lehmkuhle
• 金额: $ 99.99万
• 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/10200346
• 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; Wireless Technology; 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

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.

抽象的 Aura是一个使用Epilog™的数字健康平台 头皮下的发际线可以记录临床和亚临床癫痫发作。在初次诊断癫痫后， 癫痫学家将使用有关患者癫痫发作的已知信息来指导最佳的头皮位置，以放置 Epilog EEG传感器（a）。脑电图数据被连续传输（b）到一个人的智能手机上的Aura应用程序（C） 使用安全的蓝牙TM通过WiFi（D）通信到Aura云平台（E）。 Epilog Eeg是 分析癫痫发作和每日数字癫痫发作日记与癫痫学家（F）共享，并将其推回到 Aura应用程序（G）。 Epilog每天都充电，可重复使用一年。 Epilog设计为谨慎，允许 在日常生活的各个方面连续使用。 数据是带有运动障碍和完整意识（ILAE）的焦点癫痫发作开始的10 s片段 1A1）从Epitel的单渠道Epilog传感器放置在左额头上。病人被录取 用于视频EEG监视作为护理标准。该癫痫发作已由三位癫痫学家独立验证。 在第一阶段，将设计基于机器的癫痫发作检测算法将被设计为首次工作 光环云检测到Epilog脑电图中的癫痫发作，包括癫痫发作，一个人可能不会有意识地知道自己是 （> 50％的癫痫发作），例如睡觉时。 Aura将运行这些专门为 Epilog的脑电图单渠道提供每日数字癫痫发作日记。 在第二阶段，AURA系统将作为基于脑电图的自动化而进入FDA清除的临床验证试验 房屋癫痫发作检测和警报系统。在第二阶段的Aura早期将被商业化为医疗 启用设备的服务业务模型。患有癫痫患者的自付费用平均为 $ 380/年。持续性脑电图学家拥有长期，可重复的脑电图，现在将具有更精确的定量 癫痫发作计数的记录，使他们能够更迅速，成功地改善患者治疗 生活质量。 Aura会让癫痫病的人们重新生活。光环提供了您在哪里的确定性 当您需要时。通过第二阶段，身体，心理，行为和环境因素 将在Aura应用中合并，以收集来自300名患者的27,000天的多模式数据，以创建 空前的数据集，这些特征已知会沉淀出癫痫发作。 这些数据将在第三阶段中使用，以创建一个可穿戴的可穿戴癫痫发作预测系统 结合了多模式癫痫发作降水因子的智能，创造了小时的癫痫发作概率。 Aura将严重破坏情节的管理方式，并改善癫痫病人的生活质量。