SBIR Phase II: Innovative Electroencephalography to Advance the Research and Diagnosis of Brain Disorders

SBIR 第二阶段：创新脑电图推进脑部疾病的研究和诊断

• 批准号: 1430833
• 负责人: Walter Besio
• 金额: $ 75万
• 依托单位: CREmedical Corporation
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-10-01 至 2019-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1430833&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Innovative; Electroencephalography

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is multi-fold: First, the proposed tripolar concentric ring electrode and instrumentation for acquiring brain signals, tripolar electroencephalography (tEEG), is a platform technology that has a variety of medical and commercial applications. By providing significantly clearer brain signals, tEEG will resolve conventional EEG?s major drawback of poor signal quality that clinicians and researchers have been struggling with for decades. tEEG can advance diagnosis and fill unmet clinical and research needs such as detection of biomarkers to quantify various neurological disorders. Second, commercially, tEEG can transform the market landscape and set a new standard for EEG equipment. The fundamental improvement promised by tEEG and its non-invasive nature are particularly appealing. tEEG could greatly simplify and advance the diagnosis of a wide spectrum of neurological disorders (epilepsy, sleep disorders, stroke, Parkinson?s, Alzheimer?s, etc.) and more effectively guide neurosurgical and other medical procedures. Third, the fundamental improvement in spatial resolution and artifacts rejection in EEG signals will help advance the understanding of brain activity, leading to new discoveries in the research of various brain diseases and neurological disorders. The proposed project aims to develop a portable tripolar concentric ring electrode (TCRE) electroencephalography (tEEG) recording system and perform a comprehensive clinical evaluation to demonstrate that tEEG can detect certain important brain EEG signals better than conventional EEG. EEG is the primary diagnostic tool for epilepsy, the most common serious brain disorder worldwide, but misdiagnosis occurs in up to 50% of the patients. Artifact contamination seriously hinders the effectiveness of EEG and is a root cause of misdiagnosis. tEEG automatically suppresses artifacts and increases the interpretability of EEG through two inventions: (1) a transformative electrode configuration - the TCRE; and (2) the proprietary tEEG Interface and digitizer. The TCRE, tEEG Interface, and digitizer together comprise a complete, Portable tEEG system with the data stored and displayed on a laptop. In this project, clinicians will evaluate tEEG against conventional EEG in areas such as usability, ability to suppress artifacts, and superiority in seizure detection. If successful, tEEG would generate intense interest in the field because of the significant clinical and research impact. We expect that comparing tEEG and EEG in a clinical setting will demonstrate the superiority of tEEG for diagnosing epilepsy.

该小企业创新研究 (SBIR) 第二阶段项目的更广泛影响/商业潜力是多方面的：首先，拟议的三极同心环电极和用于获取大脑信号的仪器，三极脑电图 (tEEG)，是一种平台技术，各种医疗和商业应用。通过提供更加清晰的大脑信号，tEEG 将解决传统脑电图信号质量差的主要缺点，而临床医生和研究人员几十年来一直在努力解决这一问题。 tEEG 可以推进诊断并满足未满足的临床和研究需求，例如检测生物标志物以量化各种神经系统疾病。其次，从商业角度来看，tEEG 可以改变市场格局，并为 EEG 设备设立新标准。 tEEG 所承诺的根本性改善及其非侵入性性质特别有吸引力。 tEEG 可以极大地简化和推进多种神经系统疾病（癫痫、睡眠障碍、中风、帕金森病、阿尔茨海默病等）的诊断，并更有效地指导神经外科和其他医疗程序。第三，脑电信号空间分辨率和伪影抑制的根本提高将有助于增进对大脑活动的理解，从而为各种脑部疾病和神经系统疾病的研究带来新的发现。该项目旨在开发一种便携式三极同心环电极（TCRE）脑电图（tEEG）记录系统，并进行全面的临床评估，以证明tEEG可以比传统脑电图更好地检测某些重要的脑电图信号。脑电图是癫痫的主要诊断工具，癫痫是全世界最常见的严重脑部疾病，但高达 50% 的患者会出现误诊。伪影污染严重阻碍了脑电图的有效性，是误诊的根本原因。 tEEG 通过两项发明自动抑制伪影并提高 EEG 的可解释性：(1) 变革性电极配置 - TCRE； (2) 专有的 tEEG 接口和数字化仪。 TCRE、tEEG 接口和数字化仪共同构成一个完整的便携式 tEEG 系统，数据存储并显示在笔记本电脑上。在该项目中，临床医生将在可用性、抑制伪影的能力以及癫痫检测方面的优越性等方面评估 tEEG 与传统 EEG 的比较。如果成功，tEEG 将因其重大的临床和研究影响而引起该领域的强烈兴趣。我们期望在临床环境中比较 tEEG 和 EEG 将证明 tEEG 在诊断癫痫方面的优越性。