Accelerating Dissemination of Implantable Neurotechnology for Clinical Research

加速临床研究植入式神经技术的传播

基本信息

批准号：
10238761
负责人：
David Allenson Borton
金额：
$ 100.24万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-15 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10238761
关键词：
Address Algorithms Animals Architecture Area BRAIN initiative Behavior monitoring Biological Markers Brain Brain Diseases Chronic Clinic Clinical Clinical Protocols Clinical Research Clinical Trials Cognition Disorders Communication Communities Computer software Computers Consultations Coupled Data Set Development Devices Documentation Ecosystem Educational Materials Educational workshop Elements Ensure Epilepsy Evaluation Feedback Funding Generations Goals Grant Home Human IACUC Implant Informed Consent Infrastructure Institution Institutional Review Boards Instruction Intellectual Property International Investigation Knowledge Laboratories Lead Libraries Mental disorders Methods Mind Movement Disorders Nervous system structure Neurosciences Online Systems Patients Performance Persons Physiological Preparation Process Protocols documentation Psychiatry Readiness Regulation Regulatory Pathway Research Research Personnel Resolution Resources Risk Assessment Risk Management Signal Transduction Software Validation Stream Structure System Techniques Technology Testing Therapeutic Time Translations United States National Institutes of Health Universities Update Visualization Wireless Technology Work Writing application programming interface base brain disorder therapy data exchange data tools design education resources experience flexibility implantable device improved interest meetings neuroregulation neurotechnology new technology novel novel therapeutics open source pathway tools relating to nervous system risk mitigation symposium system architecture tool verification and validation

项目摘要

Summary Invasive neurostimulation is an established technique in the therapy of movement disorders and epilepsy, and shows promise for amelioration of psychiatric and cognitive disorders. Recently, several implantable neurostimulation hardware platforms have begun to incorporate sensing of cortical and subcortical field potential activity, with the capability for wireless streaming from the internal device to external computers over years. These high temporal and spatial resolution signals may be used for discovering the circuit basis of brain disorders, developing new therapies rationally derived from circuit analysis, and developing adaptive (feedback controlled) neurostimulation paradigms in which the device auto-adjusts according to changing brain needs. The most recent “second generation” implantable devices, such as Summit RC+S (Medtronic), have substantially improved capabilities and offer great flexibility for novel uses, at the expense of increased complexity. However, effective use of this and related platforms requires academic investigators to develop previously unfamiliar capabilities, including programming of the desired device functions using an “application programming interface”, and documenting the performance and validation of software according to FDA device regulations. While many BRAIN Initiative funded grants intend to use these second generation bidirectional interfaces, the four institutions on this proposal, working together, are the only groups that have surmounted the technical and regulatory barriers to launching clinical protocols with second generation sensing devices. We have formed the “Open Mind” neural communications consortium to share technical and regulatory infrastructure with each other and with new investigators, and begun to disseminate this knowledge at open meetings for new investigators, at the April 2018 and 2019 Brain Initiative Meetings. Through this proposal, we will greatly expand these technology dissemination activities, to provide investigators with elements critical to the launch of their own clinical studies: A “turnkey” user interface to get started that includes open source software elements for neural sensing at home and for adaptive stimulation, and a streamlined regulatory pathway for FDA approval of investigational protocols, which we call the “Open Source Quality Management System”. We will disseminate education and resources through biannual workshops and a web-based library of regulatory documents, software, and the Quality Management System. Our team represents the major clinical areas of interest in neuromodulation: movement disorders (UCSF), epilepsy (Mayo Clinic), and psychiatry (Brown/Baylor), and includes experts in the design and dissemination of implantable devices (Oxford). This consortium will facilitate already funded proposals, as well as entry of new investigators, in the rapidly evolving ecosystem of implantable wireless neural interfaces. Two new clinical teams have already begun to work with our neural sensing interface in preparation for their own clinical trials of adaptive stimulation, demonstrating readiness of tools for dissemination.

概括侵入性神经刺激是治疗运动障碍和癫痫的既定技术，并且最近，一些可植入的药物显示出改善精神和认知障碍的希望。神经刺激硬件平台已开始纳入皮质和皮质下领域的传感潜在的活动，具有从内部设备到外部计算机的无线流传输能力这些高时间和空间分辨率信号可用于发现大脑的回路基础。疾病，开发从电路分析中合理衍生的新疗法，并开发适应性受控）神经刺激范例，其中设备根据不断变化的大脑需求自动调整。最新的“第二代”植入式设备，例如 Summit RC+S（美敦力），已显着改进的功能并为新用途提供极大的灵活性，但代价是增加然而，有效使用该平台和相关平台需要学术研究人员的开发。以前不熟悉的功能，包括使用“应用程序”对所需的设备功能进行编程编程接口”，并根据 FDA 记录软件的性能和验证虽然许多 BRAIN Initiative 资助的赠款打算使用这些第二代设备。双向接口，该提案中的四个机构共同努力，是唯一拥有克服了推出第二代传感临床方案的技术和监管障碍我们成立了“Open Mind”神经通信联盟来共享技术和设备。相互之间以及与新的调查人员建立监管基础设施，并开始传播这些知识在新研究人员公开会议、2018 年 4 月和 2019 年大脑计划会议上。建议，我们将大大扩展这些技术传播活动，为调查人员提供对于启动自己的临床研究至关重要的要素：一个“交钥匙”用户界面，可以开始包括用于家庭神经传感和自适应刺激的开源软件元素，以及简化了 FDA 批准研究方案的监管途径，我们称之为“开源” 质量管理体系”。我们将通过一年两次的研讨会和传播教育和资源。基于网络的监管文件、软件和质量管理体系库。代表神经调节感兴趣的主要临床领域：运动障碍（UCSF）、癫痫（梅奥诊所）和精神病学（布朗/贝勒），并包括设计和传播植入式设备（牛津）该联盟将促进已资助的提案以及新提案的加入。研究人员在快速发展的植入式无线神经接口生态系统中研究了两种新的临床。团队已经开始使用我们的神经传感接口，为他们自己的临床试验做准备适应性刺激，展示传播工具的准备情况。