Field Deployable, Automatic, EEG Seizure Detector and Brain Dysfunction Monitor
Department of Health and Human Services
Agency Tracking Number:
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Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): The overall goal of this Fast-Track SBIR proposal is to develop a portable, low-cost, field-deployable, automatic EEG-based seizure detector and brain dysfunction monitor for general civilian population under mass casualty conditions. It is envisioned that this system will be used as an essential component of rapid and aggressive management of seizures, crucial to ameliorate neuropathology caused by nerve agent exposure in a terrorist attack. The development of this system will be based on further enhancement and integration of our several highly relevant technologies, including a commercial-grade portable, low cost, and robust intra-operative consciousness monitor that tracks patient's cortical activity in real-time during surgical procedures requiring anesthesia. The seizure detection algorithms will take advantage of our ongoing projects with the NIH and the ARMY where we are developing a novel class of seizure identification algorithms that can operate in real-time on a standard laptop. The robustness of the system will be enhanced by incorporating our novel artifact identification and removal algorithms currently supported by NINDS. The Phase I stage will develop a rugged, portable, field-deployable, seizure detector comprising of an 8- channel EEG device that is attached to a laptop that performs seizure detection and will display the seizure status in graphical format. Phase II will further miniaturize the EEG patient unit which will also contain an onboard data processing capability (DSP) and an attached screen that will display seizure status in real-time. The unit will also contain data storage and a wireless capability allowing it to communicate with a centralized station that can monitor several of these patient units simultaneously. The developed prototypes at the end of each Phase will undergo extensive simulated and actual clinical evaluations. In particular, The Phase II system will be tested in the Emergency Departments (ED) of two major health facilities, The Cleveland Clinic and University Hospitals of Cleveland, with a combined 255 patients who have been admitted to the ED and who are in need of an emergency EEG examination. The portable, low-cost, field-deployable, automatic EEG-based seizure detector and brain dysfunction monitor to be developed under this project is aimed for general civilian population under mass casualty conditions. It is envisioned that this system will be used as an essential component of rapid and aggressive management of seizures, crucial to ameliorate neuropathology caused by nerve agent exposure in a terrorist attack. The same technology is also applicable for EEG monitoring and seizure detection of military personnel subjected to a nerve gas attack in the battlefield. Finally, the developed system can be eventually become part of the general care in the Emergency Department and particularly in patients with altered mental status and those suspicious of having non-convulsive seizures and brain dysfunction.
* information listed above is at the time of submission.