High Performance Seizure Monitoring and Alert System

DESCRIPTION provided by applicant Patients are frequently hospitalized for management of uncontrolled seizures due to epilepsy or acute neurological insults such as trauma stroke infections and a number of toxic and metabolic disorders However inpatient management of seizures is complicated by the fact that they occur intermittently and unpredictably and thus it i not infrequent that patientsandapos seizures go unrecognized This can result in unnecessarily prolonged hospital stays or worse delay of treatment and irreversible brain injury Therefore there is a great need to develop an accurate bed side seizure monitroing and alert SMA system The overall goal of this SBIR project remains to be the development and commercialization of the CereScope an all in one high quality full scalp system EEG acquisition device with capability of real time signal display real time electrode impedance monitoring as well as high performance seizure monitoring and alert SMA in nearly real time Intended clinical settings include but are not limited to ambulatory EEG monitoring epilepsy monitoring units EMUs intensive care units ICUs emergency departments EDs and general care units for neurology and neurosurgical patients Researchers at Optima Neuroscience have developed several automated algorithms to accurately detect seizures for different patient populations by analyzing the spatiotemporal patterns of scalp EEG signals The algorithm for adult EMU patients was incorporated in our IdentEvent seizure detection software which received FDA approval on October During the Phase I and Phase II of this SBIR project we completed CereScopeandapos s hardware design and software implementation electric safety UL test signal quality assessment on normal volunteer subjects fully integration with the SMA module and pilot clinical study on EMU patients Building upon these achievements and with the strong support of our research teams we now propose in this Phase IIB application a pathway to expand the diagnostic utility of the CereScope It has been well documented that despite of some underlying similarities there exist significant differences in both ictal and background EEG patterns among these patient populations Therefore to ensure CereScopeandapos s clinical utility in this Phase IIB application we propose to conduct three clinical studies each in a different patient population Each clinical study will be conducted at four major medical centers These studies will evaluate how well the CereScope records video and EEG signals while simultaneously analyzing the sending alerts for possible seizure events The studies will also generate performance statistics sensitivity and false detection rate on real time seizure detection This Phase IIB has the following specific aims complete performance validation of CereScope tm for adult EMU patients complete performance validation of CereScope tm for adult ambulatory cEEG patients and complete performance validation of CereScope tm for adult ICU patients Successful commercialization of CereScope tm will improve inpatient management of seizures by allowing for detection of intermittent and previously misdiagnosed events PUBLIC HEALTH RELEVANCE Automated monitoring for critical heart and lung function has been the standard of care in all hospitals for decades However as important as it is monitoring brain functions currently relies almost exclusively upon bedside clinical observations As a result a large number of subclinical seizures only subtle observable changes go undiagnosed every day The primary goal of this project is to test a prototype for a greatly needed automated system to acquire and analyzing brain electrical activities and alert staff untrained in neurology to the presence of seizure attacks all in real time The overall goal is to improve the diagnosis and treatment of patients suffering from seizure disorders particularly in community hospitals where EEG trained neurologists may not be available