High Performance Seizure Monitoring and Alert System

高性能癫痫监测和警报系统

• 批准号: 8522316
• 负责人: Deng-Shan Shiau
• 金额: $ 68.94万
• 依托单位: OPTIMA NEUROSCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8522316
• 关键词: 17 year old; 18 year old; 3 year old; Accident and Emergency department; Acute; Adult; Age; Algorithms; Awareness; Beds; Boxing; Brain; Brain Injuries; Caring; Characteristics; Child; Childhood; Clinical; Clinical Research; Community Hospitals; Computer software; Data; Databases; Detection; Devices; Diagnosis; Electroencephalography; Ensure; Environment; Epilepsy; Evaluation; Event; Feasibility Studies; Feedback; Goals; Head; Hospitals; Infection; Inferior; Inpatients; Intensive Care Units; International; Length of Stay; Mechanics; Metabolic Diseases; Monitor; Multi-Institutional Clinical Trial; Neurologic; Neurologist; Neurology; Neurosciences; Nursing Staff; Outpatients; Pathway interactions; Patients; Pattern; Pediatrics; Performance; Phase; Physicians; Research; Research Design; Research Personnel; Respiratory physiology; Safety; Scalp structure; Seizures; Side; Signal Transduction; Small Business Innovation Research Grant; Status Epilepticus; Stroke; Study Subject; Subclinical Seizures; System; Technology; Testing; Time; Training; Trauma; base; commercialization; design; digital imaging; heart function; improved; instrument; monitoring device; patient population; prototype; research clinical testing; safety testing; simulation; spatiotemporal; standard of care; time use; user-friendly; validation studies

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 is not infrequent that patients' 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 is to commercialize an accurate, reliable, and user-friendly EEG-based seizure monitoring and alert (EEGSMA) system for use in clinical settings where patients require close neurological monitoring. Intended clinical settings include but are not limited to, 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 an automated algorithm to accurately detect seizures by analyzing the spatiotemporal patterns of scalp EEG signals. The algorithm was incorporated in our IdentEvent" seizure detection software, which received FDA approval on October 16, 2009. During the Phase I of this SBIR project, we have further completed bed-side hardware design of the SMA system and transformed IdentEvent for real-time application. The SMA system was successfully tested in simulation real-time mode, and initial clinical feasibility testing has been completed. In this Phase II application, we propose to continue the clinical testing for the SMA system as well as expand the functions of the EEGSMA system for use in acute care environments, e.g., ICUs and EDs. To accomplish this, we not only have to develop a reliable, portable, and user-friendly EEG acquisition module that can be set up quickly, but also we need to expand IdentEvent for use in children and for ICU patients. Therefore, the specific aims of this application are: (1) to complete the clinical performance evaluation of the SMA module in an EMU setting, (2) to design and test front end hardware and software components of the EEG head-box and integrate them with the SMA system, (3) to complete pre-clinical testing and pilot outpatient study of the integrated EEGSMA system, (4) to conduct inpatient testing of the integrated EEGSMA system in EMUs, (5) to test the detection algorithm (IdentEvent) on pediatric patients (age 3 ~ 17) in EMUs, and (6) to further develop a seizure detection algorithm for ICU patients. Successful commercialization of this EEGSMA device will improve inpatient management of seizures by allowing for detection of intermittent and previously misdiagnosed events.

描述（由申请人提供）：由于癫痫或急性神经系统侮辱，例如创伤，中风，感染以及许多有毒和代谢疾病，因此经常住院治疗不受控制的癫痫发作。然而，由于间歇性地发生，不可预测的事实使癫痫发作的住院治疗变得复杂，因此并非罕见的患者的癫痫发作尚未得到认可。这可能导致不必要的延长医院住院，或者更糟的是，治疗延迟和不可逆的脑损伤。因此，非常需要开发准确的卧床癫痫发作和警报（SMA）系统。 该SBIR项目的总体目标是将基于脑电图的精确，可靠和用户友好的癫痫发作监测和警报（EEGSMA）系统商业化，以在患者需要密切神经系统监测的临床环境中使用。预期的临床环境包括但不限于癫痫监测单元（EMU），重症监护病房（ICU），急诊科（EDS）以及神经病学和神经外科患者的一般护理部门。 Optima神经科学的研究人员通过分析头皮EEG信号的时空模式，开发了一种自动化算法来准确检测癫痫发作。该算法已纳入我们的“鉴定检测软件”，该软件在2009年10月16日获得了FDA批准。在此SBIR项目的第一阶段，我们已经进一步完成了SMA系统的床旁硬件设计，并改换了确定性的确定性，以进行实时应用。SMA系统在临床上的临床临床临床临床上已成功进行了临床测试，并在此阶段进行了临床测试。测试SMA系统以及在急性护理环境中使用的EEGSMA系统的功能，例如ICU和ED，我们不仅必须开发可靠的，便携式和用户友好的EEG默认审查模块，这些模块可以迅速设置，还需要在儿童中进行启动。在EMU设置中对SMA模块的评估，（2）设计和测试EEG头盒的前端硬件和软件组件，并将它们与SMA系统集成在一起，（3）以完成临床前测试和综合EEGSMA系统的试验门诊研究（（4）进行集成eegs System（4）的eegs System（5）emus（5）emus（5），（4）在EMU中的小儿患者（3〜17岁）和（6）上，以进一步为ICU患者开发癫痫发作算法。 该EEGSMA设备的成功商业化将通过允许检测间歇性和以前误诊的事件来改善癫痫发作的住院治疗。