Epilepsy Seizure Detection with Innovative Tripolar EEG (tEEG)

使用创新的三极脑电图 (tEEG) 检测癫痫发作

• 批准号: 10455502
• 负责人: Walter Grant Besio
• 金额: $ 54.35万
• 依托单位: CREMEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10455502
• 关键词: Alpha Rhythm; Blinking; Brain; Brain Diseases; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Communities; Complex; Computer Simulation; Data; Detection; Development; Devices; Diagnosis; Diffuse; Effectiveness; Electrocardiogram; Electrodes; Electroencephalography; Epilepsy; Equipment; Evaluation; Frequencies; Head; High Frequency Oscillation; Industry Standard; Institutional Review Boards; Marketing; Measures; Morphologic artifacts; Muscle; Noise; Patients; Pattern; Persons; Phase; Preclinical Testing; Preparation; Process; Reader; Regulatory Affairs; Research; Research Personnel; Resolution; Rest; Safety; Seizures; Sensitivity and Specificity; Signal Transduction; Site; Small Business Innovation Research Grant; System; Technology; Testing; Time; Visual; brain electrical activity; clinical risk; clinical trial protocol; commercialization; computerized; design; design verification; experience; improved; innovation; interest; manufacture; multidisciplinary; neurophysiology; prototype; research clinical testing; sensor; success; usability; voltage

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.

项目总结