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

无创头皮检测脑损伤皮质扩散性抑制

• 批准号: 9660725
• 负责人: Stephen Carter Jones
• 金额: $ 5万
• 依托单位: SCIENCEPLUSPLEASE, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9660725
• 关键词: Acute Brain Injuries; Address; Algorithms; Amplifiers; Auras; Base of the Brain; Brain; Brain Concussion; Brain Injuries; Businesses; Cessation of life; Clinical Research; Collection; Coupled; Detection; Development; Device Designs; Devices; Electrodes; Electroencephalography; Engineering; Evaluation; Event; Goals; Grant; Head; Industry; Innovation Corps; Intensive Care Units; Interview; Knowledge; Legal patent; Life; Marketing; Medical; Medical Device; Methods; Migraine; Monitor; Non-Invasive Cancer Detection; Patient Monitoring; Patient-Focused Outcomes; Patients; Pharmacologic Substance; Phase; Procedures; Production; Rehabilitation therapy; Research Personnel; Resources; Savings; Scalp structure; Signal Transduction; Skin; Small Business Innovation Research Grant; Spreading Cortical Depression; Stroke; Subarachnoid Hemorrhage; Surface; System; Technology; Therapeutic; Training; Traumatic Brain Injury; United States National Institutes of Health; Validation; base; cooperative study; design; digital; experience; improved; injured; interest; neurosurgery; next generation; outreach; prevent; programs; prototype; signal processing; targeted treatment

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.

NIH I-Corps™计划的补充申请将提供资源和培训， 客户发现访谈，将为我们的同品种产品第一阶段的生产和业务开发提供信息 SBIR资助NS 092181，题为“脑损伤皮层扩散性抑制的无创头皮检测” 这笔赠款用于开发和验证我们的非侵入性检测概念验证设备 急性脑损伤，包括中风，蛛网膜下腔出血， 以及严重的脑外伤该设备将解决非侵入性CSD检测的未满足需求， 目前唯一被接受的方法是涉及放置在脑表面上的电极的侵入性过程 在必要的神经外科手术中因此，只有一小部分最严重的受伤患者是 监控。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损害性CSD的发生，除了解决偏头痛治疗， 现在已知偏头痛先兆的先兆抑制是CSD的结果。我们的概念验证原型是 由具有直流电（DC）能力的电极的专有配置组成，使用 市售的DC耦合生物信号放大器，考虑DC耦合的信号处理 在皮肤表面处产生的电势，以及数字CSD检测算法。一项专利正在进行最后审查， 设备的核心技术。一旦非侵入性CSD检测得到验证，我们的概念验证原型- 类型将是用于检测常规神经重症监护室（Neuro-ICU）使用的CSD的设备的基础。我们 旨在探索客户和利益相关者对我们的头皮安装式CSD检测系统的需求。我们的第一支矛- 主要客户是使用目前的非侵入性技术进行了许多临床研究的研究人员， CSD检测系统和脑损伤去极化合作研究（COSBID， http://www.cosbid.org）组。这些神经ICU的研究人员相信，CSD靶向治疗， 馅饼将减少创伤后脑损伤的扩大，并准备一个设备，将大大扩大他们的 评估和验证这些疗法的能力。其他利益相关者包括：1）制药公司， 将使用非侵入性CSD监测来客观评价抗先兆/CSD疗法和抗CSD 减少基于CSD的脑损伤扩展的疗法;以及2）对新的 产品为新市场。我们的团队由同品种I期SBIR的PI和com的CEO组成， 我们的原型设备的详细知识，该公司的系统工程师，作为科学家， 技术专家，可以直接将利益相关者关注的问题纳入我们的下一代设计 设备，以及在产品推广和营销方面拥有广泛经验的行业专家。我们的目标是 提供一种可销售的、易于使用的器械，设计用于神经ICU的常规使用， 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。