Epilepsy Seizure Detection with Innovative Tripolar EEG (tEEG)

项目总结 脑电(EEG)是评估癫痫的一个重要组成部分，癫痫是最常见的 世界范围内的严重脑部疾病。癫痫的误诊非常常见，高达50%的患者 病人。伪影污染严重阻碍了脑电的有效性，是误诊的根本原因。 CREMedical正在开发一种三极同心圆环电极(TCRE)传感器和一种可记录 TIPOLAR EEG(TEEG)和仿真EEG(EEEG)。泰格解决了传统技术的根本缺陷 EEG，在信号保真度、空间分辨率和更高频率的记录方面提供显著改进 大脑活动，这是常规脑电缺乏的地方。在癫痫患者群体中，人们对 分析高频振荡(HFO)以定位致痫区域。 该SBIR快速通道项目的总体目标是完成必要的非临床和临床 为使该设备能够从实验室过渡到临床使用而开展的活动。该项目集成了 在技术、癫痫、神经生理学和监管事务方面的多学科专业知识。 第一阶段的目标是完成商业化所需的非临床开发活动 以及启动癫痫临床试验的IRB批准。 PHI-里程碑1：从FDA获得明确的非约束性指示，说明我们建议的临床试验方案是 可能足以获得510(K)监管许可。 PHI-里程碑2：获得IRB确认拟议的临床前测试和临床方案是 适用于支持无重大风险(NSR)临床试验。 PHI-里程碑3：开发头部模型和计算机模拟，以测试本地参考的贡献。 PHI-里程碑4：建立设计和质量系统控制流程。 PHI-里程碑5：根据法规和行业标准在中执行设计验证和确认。 第二阶段的目标是证明TEEG设备在记录电信号方面的安全性和有效性 癫痫患者的脑活动为获得FDA批准做准备。 PHII-里程碑1：经过验证的可用性。(A)脑电技术员在应用和移除脑电波时是否有问题 TCRE？(B)TEEG和eEEG数据是否可解释？(C)TEEG和eEEG是否可以记录以下模式 同时进行常规脑电检查也可以看到吗？ PHII-里程碑2：泰格在神器抑制方面的优势。 PHII-里程碑3：TEEG在癫痫检测方面的优势。 PHII-里程碑4：脑电同步记录与TEEG用于癫痫发作的比较 本地化。

PROJECT SUMMARY Electroencephalography (EEG) is an essential component in the evaluation of epilepsy, the most common serious brain disorder worldwide. Misdiagnosis of epilepsy is very common and occurs in up to 50% of the patients. Artifact contamination seriously hinders the effectiveness of EEG and is a root cause of misdiagnosis. CREmedical is developing a tripolar concentric ring electrode (TCRE) sensor and a t-Interface that registers tripolar EEG (tEEG) and emulated EEG (eEEG). tEEG resolves the fundamental drawbacks of conventional EEG, providing significant improvement in signal fidelity, spatial resolution, and registering of higher frequency brain activities, where conventional EEG is lacking. There is increasing interest in the epilepsy community in analyzing high-frequency oscillations (HFOs) for localizing epileptogenic zones. The overall objective of this SBIR fast-track project is to complete the necessary non-clinical and clinical activities in order to enable the transition of the device from lab to clinical use. This project integrates multidisciplinary expertise in technology, epilepsy, neurophysiology, and regulatory affairs. The Phase I objective is to complete the non-clinical development activities necessary for commercialization and obtaining IRB approval for initiating a clinical trial in epilepsy. Ph I - Milestone 1: Obtain clear non-binding indication from the FDA that our proposed clinical trial protocol is likely sufficient to obtain a 510 (k) regulatory clearance. Ph I - Milestone 2: Obtain IRB confirmation that the proposed pre-clinical testing and clinical protocol are appropriate to support the non-significant risk (NSR) clinical trial. Ph I - Milestone 3: Develop head phantom and computer simulation to test contribution of local reference. Ph I - Milestone 4: Establish Design and Quality Systems Control process. Ph I - Milestone 5: Perform design verification and validation in pursuant to regulatory and industry standards. The Phase II objective is to demonstrate the safety and efficacy of the tEEG device in recording electrical brain activities in persons with epilepsy in preparation for obtaining FDA clearance. Ph II – Milestone 1: Proven usability. (A) Do EEG technologists have problems applying and removing the TCREs? (B) Are the tEEG and eEEG data interpretable? (C) Can tEEG and eEEG record patterns that are also visible with concurrent conventional EEG? Ph II – Milestone 2: Superiority of tEEG for artifacts suppression. Ph II – Milestone 3: Superiority of tEEG for seizure detection. Ph II – Milestone 4: Comparison between simultaneous intracranial recordings and tEEG for seizure localization.