Aura is a digital health platform that uses Epilogâ¢, a miniature, wireless, wearable EEG sensor worn on thescalp below hairline that can record clinical and subclinical seizures. After an initial diagnosis of epilepsy, anepileptologist will use known information about patients' seizures to guide the best scalp location to place theEpilog 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 isanalyzed for seizures and a daily digital seizure diary is shared with epileptologists (F) and pushed back to theAura app (G). Epilog is recharged daily, and reusable for a year. Epilog is designed to be discreet, allowing forcontinuous 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 (ILAE1A1) recorded from Epitel's single-channel Epilog sensor placed on the left forehead. The patient was admittedfor 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 theAura cloud to detect seizures in Epilog EEG, including seizures a person may not consciously know they arehaving (>50% of all seizures), such as while sleeping. Aura will run these algorithms developed exclusively forEpilog'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 automatedhome seizure detection and alerting system. Early in Phase II Aura will be commercialized as a medicaldevice-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, quantitativerecord of seizure counts, enabling them to adapt patient treatment more rapidly and successfully to improvequality of life. Aura will give people living with epilepsy their lives back. Aura provides certainty where you areand when you need it. Throughout Phase II, physiological, psychological, behavioral, and environmental factorswill be combined in the Aura app to collect 27,000 days of multi-modal data from 300 patients to create anunprecedented dataset of features known to precipitate seizures.These data will be used in Phase III to create a robust, wearable seizure forecasting system using artificialintelligence 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.
Public Health Relevance Statement: This grant proposal aims to create a digital health platform that includes a wearable medical device worn on the
scalp below the hairline. The system detects and counts seizures, and alerts to seizures in real time. The goal
is to empower people with epilepsy to take control of their seizure monitoring and help improve the treatment of
epilepsy.
Project Terms:
