Bridging bench to bedside with aneurotechnology cross-development platform

通过神经技术交叉开发平台将工作台与床边桥接起来

• 批准号: 10640424
• 负责人: David Allenson Borton
• 金额: --
• 依托单位: PROVIDENCE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10640424
• 关键词: Acceleration; Address; Affect; Age; Algorithm Design; Algorithms; American; Amplifiers; Architecture; Brain; Capital; Caring; Chronic; Clinical Research; Collaborations; Communication; Communities; Complex; Computer software; Computers; Custom; Data; Detection; Development; Device or Instrument Development; Devices; Disease; Drug Costs; Economic Burden; Ecosystem; Electrodes; Electronics; Electrophysiology (science); Evaluation; Feedback; Future; Goals; Growth; Health Care Costs; Human Resources; Implant; Injury; Intellectual Property; Intervention; Investigation; Investments; Knowledge; Laws; Liquid substance; Logic; Longitudinal Studies; Manufacturer; Marketing; Medical; Medical Device; Mission; Nervous System; Nervous System Trauma; Neurologic; Neurology; Neurostimulation procedures of spinal cord tissue; Operating System; Parkinson Disease; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Research; Resources; Risk; Sensorimotor functions; Services; Shapes; Sheep; Spinal; Spinal Cord; Spinal cord injury; System; Technology; Telemetry; Testing; Textiles; Therapeutic; Thinness; Time; Transistors; Translations; Tremor; United States Department of Veterans Affairs; United States Food and Drug Administration; Vertebral column; Veterans; Writing; bench to bedside; bioelectronics; chronic pain; cost; data acquisition; deep brain stimulator; density; design; first-in-human; flexibility; human study; implantable device; improved; in vivo; innovation; instrument; manufacture; medical implant; microchip; nervous system disorder; neural; neuroregulation; neurotechnology; new technology; next generation; novel; novel therapeutics; pharmacologic; pre-clinical; preclinical evaluation; preclinical study; premature; programs; research and development; research clinical testing; restoration; socioeconomics; spinal cord and brain injury; success; timeline; tool; wireless

Advancements in neurotechnology are shaping the future of medical care for those suffering from neurological illness, disease, and injury. Unfortunately, it can take decades to bring such advances from the benchtop to the bedside in service of our Veterans. The development, evaluation, optimization, and deployment of each subcomponent of a medical device is complex, and combinations of technologies are required to address the complex needs of Veterans with, for example, traumatic brain and spinal cord injuries. In fact, the last major neurotechnology translational success was arguably the deep brain stimulator (DBS) developed in the 1980’s, delivering electrical neuromodulation to the brain to reduce Essential and Parkinson’s Disease-related tremor, but were not approved by the Food and Drug Administration until 2002. While impressive technologies are on the horizon, including those supported by the Department of Veterans Affairs, the time, money, and scientific divide between benchtop successes and bedside therapeutic application is exceptionally vast. Bioelectronics are hyped as an alternative to drug interventions, but the reality is that the translation timelines for medical devices—and their success rates as therapeutic tools—mirror the slow and costly development of new pharmaceuticals rather than mirroring the lean, accelerated development of new electronics for the consumer market. This issue matters because the socioeconomic burden of neurological injury and disorders is significant. Spinal cord injuries (SCIs) alone are estimated to affect between 249,000 and 363,000 Americans (NSCISC), and roughly 42,000 people with SCIs are Veterans, an estimated $5M/patient over their lifetime in health care costs. Nearly half of all SCIs occur in people between the ages of 16 and 30, leaving many to live with the injuries for decades. The inefficiency of bringing new drugs to market is dubbed “Eroom’s” law, given the exponentially increasing cost of drug release—in contrast to Moore’s law, originally referring to the number of transistors on a microchip doubling every 2 years though the cost of computers is halved, but more generally illustrating the exponential growth for technologies over time. From a translational perspective, the efficiency of medical device innovation still has much more in common with pharmacological research and development (R&D) than it does with Moore’s law and consumer electronics. We propose the development of a hardware and software accelerator platform (“cross-development”, or xDev) for electrophysiology research and neurotechnology creation. Development of this platform would enable new research into spinal cord stimulation for sensorimotor restoration in SCI, as well as for continued investigation of spinal electrophysiology in closed-loop devices for chronic pain. The new tool will be used to accelerate design, development and deployment of neurotechnology by smoothing the transition between design phases, allowing rapid redesign and re-verification of neurotechnology components. The xDev platform maximizes the ability of neurotechnology device developers to test their tools with versatile interfaces, algorithms, and underlying chipsets, improving compatibility, cross-functionality, and inspiring new collaborations between technology developers. Strategic platform organization protects neurotechnology developers’ intellectual property, while improving modularity with tools from other manufacturers. Leveraging the xDev platform, we will demonstrate a new neurotechnology enabling chronic recording of spinal electrophysiology and fill a neuroscientific knowledge gap, connecting the fields of Restorative Neurology and therapeutic spinal cord neuromodulation.

神经技术的进步正在塑造神经疾病患者的医疗保健的未来 疾病、疾病和伤害。不幸的是，可能需要几十年的时间才能将这样的进步从台式机带到 在床边为我们的退伍军人服务。每个组件的开发、评估、优化和部署 医疗器械的子部件是复杂的，需要各种技术的组合来解决 例如，患有创伤性脑和脊髓损伤的退伍军人的复杂需求。事实上，上一个重大事件 神经技术翻译的成功可以说是上世纪80年代S开发的深部脑刺激器(DBS)， 向大脑传递电神经调节，以减少与原发性和帕金森氏症相关的震颤， 但直到2002年才得到美国食品和药物管理局的批准。当令人印象深刻的技术正在进行时 地平线，包括退伍军人事务部支持的那些，时间，金钱和科学 台式电脑的成功和床边治疗应用之间的差距异常巨大。生物电子学 被炒作为药物干预的替代方案，但现实是，医疗服务的翻译时间表 设备-以及它们作为治疗工具的成功率-反映了新技术开发的缓慢和昂贵 制药公司不是反映了面向消费者的新电子产品的精益、加速开发 市场。 这个问题之所以重要，是因为神经损伤和紊乱的社会经济负担是巨大的。脊椎 据估计，仅脊髓损伤(SCI)就影响了24.9万至36.3万美国人(NSCISC)，以及 大约42,000名SCI患者是退伍军人，据估计，在他们的一生中，每个患者在医疗保健方面的收入为500万美元 成本。几乎一半的SCI发生在16岁到30岁之间的人群中，留下了许多人生活在 几十年的伤痕累累。将新药推向市场的低效被称为“埃罗姆定律”，因为 成倍增加的药物释放成本-与摩尔定律相反，摩尔定律最初指的是药物释放的数量 微芯片上的晶体管每两年翻一番尽管计算机的成本减半，但更普遍的是 说明了技术随着时间的推移呈指数级增长。从翻译的角度来看， 医疗器械创新仍然与药理学研究和开发有更多的共同点 (研发)比摩尔定律和消费电子产品更重要。 我们建议开发一个硬件和软件加速器平台(“交叉开发”，或XDev) 用于电生理学研究和神经技术创造。该平台的开发将使新的 脊髓刺激促进脊髓损伤后感觉运动恢复的研究及后续研究 脊椎电生理学在治疗慢性疼痛的闭环系统中的应用。新工具将用于加速 通过平滑设计阶段之间的过渡来设计、开发和部署神经技术， 允许对神经技术组件进行快速重新设计和重新验证。XDev平台最大限度地 神经技术设备开发人员使用多种接口、算法和工具测试工具的能力 底层芯片组，提高兼容性、交叉功能，并激发 技术开发人员。战略平台组织保护神经技术开发人员的智力 属性，同时使用其他制造商的工具改进模块化。利用XDev平台，我们将 展示一种新的神经技术，能够长期记录脊髓电生理并填补 神经科学知识鸿沟，连接恢复性神经病学和治疗脊髓领域 神经调节。