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

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是多方面的：首先，拟议的三极同心环电极和用于采集大脑信号的仪器，三极脑电图（tEEG），是一种具有各种医疗和商业应用的平台技术。通过提供明显更清晰的大脑信号，tEEG将解决传统EEG？这是临床医生和研究人员几十年来一直在努力解决的信号质量差的主要缺点。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，在商业上，tEEG可以改变市场格局，为EEG设备设定新的标准。tEEG承诺的根本性改进及其非侵入性性质特别吸引人。tEEG可以极大地简化和促进广泛的神经系统疾病（癫痫，睡眠障碍，中风，帕金森？老年痴呆症？s等）并且更有效地指导神经外科和其它医疗过程。第三，EEG信号中空间分辨率和伪影抑制的根本性改善将有助于促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获得新的发现。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EEG更好地检测某些重要的大脑EEG信号。脑电图是癫痫的主要诊断工具，癫痫是世界上最常见的严重脑部疾病，但误诊率高达50%。脑电污染严重影响脑电图的有效性，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;以及（2）专有的tEEG接口和数字化仪。TCRE、tEEG接口和数字化仪共同组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。在本项目中，临床医生将在可用性、抑制伪影的能力和癫痫发作检测的优越性等方面对tEEG与传统EEG进行评价。如果成功，tEEG将在该领域产生强烈的兴趣，因为它具有重大的临床和研究影响。我们希望在临床环境中比较tEEG和EEG将证明tEEG诊断癫痫的优越性。

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.