U44NS121562

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 the 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 Bluetooth™ 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.

Epitel

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Salt Lake City, Utah 841113369 United States

Single Zip Code

Translational Neural Devices (U44 - Clinical Trial Required) (RFA-NS-18-012)

Amendment Since initial award the End Date has been extended from 04/30/23 to 04/30/26 and the total obligations have increased 527% from $999,853 to $6,268,747.