Non-invasive scalp detection of cortical spreading depression for brain injury

NIH I-Corps™计划的这一补充申请将提供资源和培训，以进行 客户发现访谈，将为我们的谓词第一阶段的生产和业务发展提供信息 SBIR授予NS092181题为“脑损伤时非侵入性头皮检测皮质扩散性抑制” 这笔赠款用于开发和验证我们用于非侵入性检测的概念验证设备 皮质扩散性去极化(CSD)在急性脑损伤中的作用，包括中风，蛛网膜下腔出血， 和严重创伤性脑损伤。该设备将满足对非侵入性CSD检测的未满足需求 目前唯一被接受的方法是在大脑表面放置电极的侵入性手术。 在医学上有必要的神经外科手术期间。因此，只有一小部分最严重的受伤患者 被监视着。非侵入性CSD检测将用于开发和监测重复性脑损伤的治疗 在所有形式的急性脑损伤中发生破坏性CSD，除了解决偏头痛的治疗方法外 作为偏头痛的先兆，先兆抑制现在被认为是CSD的结果。我们的概念验证原型是 由支持直流(DC)的电极的专有配置组成，信号采集使用 市面上可买到的直流耦合生物信号放大器，考虑直流的信号处理 在皮肤表面产生的电位，以及数字CSD检测算法。一项专利正在接受最终审查，以 该装置的核心技术。一旦非侵入性CSD检测得到验证，我们的概念验证原型- 类型将是检测常规神经重症监护病房(Neuro-ICU)使用的CSD的设备的基础。我们 目的探索客户和利益相关者对我们的头皮安装的CSD检测系统的需求。我们的第一支长矛- 主要客户是使用当前的非侵入性技术进行了许多临床研究的研究人员 CSD检测系统和参与脑损伤去极化合作研究(COSBID， Http://www.cosbid.org)组。这些以神经ICU为基础的调查人员相信，CSD靶向的Thera- 馅饼将减少脑损伤后的扩张，并为一种设备做好准备，这种设备将大大扩大他们的 评估和验证此类疗法的能力。其他利益相关者包括：1)制药公司 将使用非侵入性CSD监测来客观评估抗AURA/CSD治疗和抗CSD 减少基于CSD的脑损伤扩展的治疗方法；以及2)医疗设备公司对新的 面向新市场的产品。我们的团队由谓词一期SBIR的PI和COM的CEO组成- 公司对我们的原型设备有详细的了解，公司的系统工程师作为科学 技术专家，他可以直接将利益相关者的关切落实到我们的下一代设计中 以及一位在产品推广和市场营销方面拥有广泛经验的行业专家。我们的目标是 提供一种适销对路、易于使用的设备，专为神经ICU的常规使用而设计，将用于 监测挽救大脑的疗法，这些疗法将缩短康复时间，延长生命，防止死亡。

This supplemental application for the NIH I-Corps™ program will provide resources and training to conduct customer discovery interviews that will inform production and business development for our predicate Phase I SBIR grant NS092181 entitled "Noninvasive scalp detection of cortical spreading depression for brain injury" This grant provides for the development and validation our proof-of-concept device for non-invasive detection of cortical spreading depolarization (CSD) in acute brain injury, including stroke, subarachnoid hemorrhage, and severe traumatic brain injury. The device will address the unmet need for a noninvasive CSD detection as the only currently accepted method is an invasive procedure involving electrodes placed on the brain surface during medically necessitated neurosurgery. Thus only a small fraction of the most critically injured patients are monitored. Noninvasive CSD detection will be used to develop and then monitor treatments of repetitive, brain damaging CSD occurrence in all forms of acute brain injury, in addition to addressing migraine therapies for aura suppression as migraine aura is now known to be the result of CSDs. Our proof-of-concept prototype is composed of a proprietary configuration of direct current (DC)-capable electrodes, signal collection using commercially available DC-coupled bio-signal amplifiers, signal processing with consideration for the DC potentials created at the skin surface, and a digital CSD detection algorithm. A patent is under final review for the core technology of the device. Once non-invasive CSD detection is validated, our proof-of-concept proto- type would be the basis for a device to detect CSD for routine Neuro-Intensive Care Unit (Neuro-ICU) use. We aim to explore customer and stakeholder needs for our scalp-mounted, CSD-detection system. Our first spear- head customers are investigators who have performed many clinical studies using the current non-invasive CSD detection system and who are part of the CoOperative Study on Brain Injury Depolarisations (COSBID, http://www.cosbid.org) group. These Neuro-ICU-based investigators are convinced that CSD-targeted thera- pies will reduce post-injury brain injury expansion and are primed for a device that will greatly expand their ability to evaluate and validate such therapies. Other stakeholders include: 1) pharmaceutical companies who would use non-invasive CSD monitoring for the objective evaluation of anti-aura/CSD therapies and anti-CSD therapies to reduce CSD-based brain injury expansion; and 2) medical device companies interested in a new product for a new market. Our team is composed of the PI of the predicate Phase I SBIR and CEO of the com- pany with detailed knowledge of our prototype device, the System Engineer of the company as the Scientific Technical Expert, who can directly implement stakeholder concerns into the design of our next generation device, and an industry expert with a wide-ranging experience in product out-reach and marketing. Our goal is to provide a marketable, easy-to-use device designed for routine use in the Neuro-ICU that will be used to monitor brain-saving therapies that will reduce the duration of rehabilitation, extend life, and prevent death.