SBIR Phase I: Innovative Tripolar Concentric Ring Electrode Electroencephalography (tEEG) to Advance Epilepsy Diagnosis

SBIR 第一阶段：创新的三极同心环电极脑电图 (tEEG) 推进癫痫诊断

• 批准号: 1248654
• 负责人: Walter Besio
• 金额: $ 14.99万
• 依托单位: CREmedical Corporation
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1248654&HistoricalAwards=false
• 关键词: SBIR; Phase; Innovative; Tripolar; Concentric

This Small Business Innovation Research Phase I project aims to establish the feasibility of innovative tripolar concentric ring electrode electroencephalography (tEEG) for epilepsy diagnosis. Epilepsy is the most common serious brain disorder worldwide. Presently, EEG is the primary diagnostic tool for epilepsy, but misdiagnosis occurs in up to 50% of the patients. The root cause of misdiagnosis lies in the poor signal fidelity of EEG which stems in part from signal contamination with noise. The proposed tEEG technology achieves superior signal fidelity through two inventions: (1) the tripolar concentric ring electrode (TCRE), a transformative electrode configuration which overcomes the limitations of the conventional electrode; and (2) a proprietary interface circuit which serves as a preamplifier to conventional EEG amplifiers. This project will accomplish two specific aims. The first aim is to improve the design of the clinical tEEG prototype. The second aim is to evaluate tEEG against conventional EEG in adult and pediatric patients with epilepsy. Success will be determined by expert review and quantitative analysis. tEEG is expected to exhibit higher interpretability and quantitative performance than conventional EEG, helping improve epilepsy diagnosis.The broader impact/commercial potential of this project is three-fold: (1) Commercial Value. tEEG is a platform technology that has a variety of medical and commercial applications. By providing significantly higher fidelity which leads to improved signal interpretability, tEEG will resolve conventional EEG?s major drawback and a fundamental problem that clinicians and researchers have been struggling with for decades. tEEG can advance diagnosis and fill unmet clinical and research needs. Commercially, tEEG can transform the market landscape and set a new standard for EEG equipment. (2) Societal Impact. The fundamental improvement promised by tEEG and its non-invasive nature are particularly appealing. tEEG has the potential to greatly simplify and advance the diagnosis of a wide spectrum of neurological disorders and more effectively guide neurosurgical and other medical procedures. (3) Enhanced Scientific and Technological Understanding. tEEG can benefit a host of brain and behavioral research areas. The fundamental improvement in signal fidelity and artifacts rejection will help advance the understanding of brain activity, leading to new discoveries in the research of various brain diseases and neurological disorders. The increased signal fidelity from tEEG may advance research of biomarkers to quantify neurological disorders with tEEG which was not previously possible.

该小企业创新研究第一阶段项目旨在建立创新三极同心环电极脑电图（tEEG）用于癫痫诊断的可行性。癫痫是全世界最常见的严重脑部疾病。目前，脑电图是癫痫的主要诊断工具，但高达50%的患者出现误诊。误诊的根本原因在于脑电图信号保真度差，部分原因是信号受到噪声污染。所提出的tEEG技术通过两项发明实现了卓越的信号保真度：（1）三极同心环电极（TCRE），一种克服传统电极局限性的变革性电极配置； (2) 专有接口电路，用作传统脑电图放大器的前置放大器。该项目将实现两个具体目标。第一个目标是改进临床 tEEG 原型的设计。第二个目的是评估成人和儿童癫痫患者的 tEEG 与传统 EEG 的比较。成功与否将通过专家评审和定量分析来确定。 tEEG 预计将比传统 EEG 表现出更高的可解释性和定量性能，有助于改善癫痫诊断。该项目更广泛的影响/商业潜力有三重：（1）商业价值。 tEEG 是一种具有多种医疗和商业应用的平台技术。通过提供显着更高的保真度，从而改善信号的可解释性，tEEG 将解决传统 EEG 的主要缺点以及临床医生和研究人员数十年来一直在努力解决的基本问题。 tEEG 可以推进诊断并满足未满足的临床和研究需求。在商业上，tEEG 可以改变市场格局并为 EEG 设备设立新标准。 (2)社会影响。 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 有潜力极大地简化和推进多种神经系统疾病的诊断，并更有效地指导神经外科和其他医疗程序。 （三）增强科学技术认识。 tEEG 可以使许多大脑和行为研究领域受益。信号保真度和伪影抑制的根本改善将有助于增进对大脑活动的理解，从而在各种脑部疾病和神经系统疾病的研究中带来新的发现。 tEEG 信号保真度的提高可能会推进生物标志物的研究，以通过 tEEG 量化神经系统疾病，这在以前是不可能的。