Accelerating Dissemination of Implantable Neurotechnology for Clinical Research

加速临床研究植入式神经技术的传播

• 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
• 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

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.

摘要 侵入性神经刺激是治疗运动障碍和癫痫的一项既定技术， 显示出改善精神和认知障碍的希望。最近，几个植入物 神经刺激硬件平台已经开始整合皮质和皮质下视野的感知 潜在活动，具有从内部设备无线传输到外部计算机的功能 好几年了。这些高时间和空间分辨率的信号可能被用来发现大脑的电路基础 障碍，从电路分析中合理地开发新的治疗方法，以及开发适应性(反馈 受控)神经刺激范例，其中设备根据不断变化的大脑需求进行自动调整。 最新的“第二代”植入式装置，如顶峰RC+S(美敦力)，已经 显著提高了功能，并为新的用途提供了极大的灵活性，但代价是 复杂性。然而，要有效利用这个平台和相关平台，需要学术研究人员开发 以前不熟悉的功能，包括使用应用程序对所需设备功能进行编程 编程接口“，并根据FDA的要求记录软件的性能和验证 设备法规。虽然许多Brain Initiative资助的赠款打算使用这些第二代 双向接口，这项提案的四个机构，共同努力，是唯一拥有 利用第二代传感技术跨越推出临床方案的技术和法规障碍 设备。我们成立了“开放思维”神经通讯联盟，以分享技术和 与监管基础设施相互联系，并与新的调查人员合作，并开始传播这一知识 在新调查人员的公开会议上，在2018年4月和2019年大脑倡议会议上。通过这件事 建议，我们将大大扩大这些技术传播活动，为调查人员提供 对启动自己的临床研究至关重要的要素：开始进行临床研究的“交钥匙”用户界面 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，我们将其称为“开放源代码” 质量管理体系“。我们将通过每两年举办一次的讲习班和 基于网络的法规文件、软件和质量管理系统资料库。我们队 代表了神经调节的主要临床领域：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 植入式装置(牛津)。这个联合体将促进已经获得资金的提案，以及新的 研究人员在快速发展的植入式无线神经接口生态系统中说。两个新的临床 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，表明已准备好传播工具。