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Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

Award Number: U44NS121562
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,294,567 )
2025	2025	EPITEL, INC	465 S 400 E STE 250	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	8/15/2025	NON-COMPETING CONTINUATION	$1,294,567
														Subtotal = $1,294,567

Issue Date FY: 2024 ( Subtotal = $1,298,163 )
2024	2024	EPITEL, INC	465 S 400 E	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	6/27/2024	NON-COMPETING CONTINUATION	$1,298,163
														Subtotal = $1,298,163

Issue Date FY: 2023 ( Subtotal = $1,683,078 )
2023	2023	EPITEL, INC.	465 SOUTH 400 EAST	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	5/19/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,683,078
														Subtotal = $1,683,078

Issue Date FY: 2022 ( Subtotal = $993,086 )
2022	2022	EPITEL, INC.	630 S STRINGFELLOW CT	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	5/17/2022	NON-COMPETING CONTINUATION	$993,086
														Subtotal = $993,086

Issue Date FY: 2021 ( Subtotal = $999,853 )
2021	2021	EPITEL, INC.	630 S STRINGFELLOW CT	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	5/6/2021	NEW	$999,853
														Subtotal = $999,853

Grand Total All Awards = $6,268,747

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Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

Award Number: U44NS121562

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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