Beekeeper Administrative Core for COSMIIC HORNET

COSMIIC HORNET 的养蜂人管理核心

• 批准号: 10549467
• 负责人: KEVIN L. KILGORE
• 金额: $ 76.54万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-10 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10549467
• 关键词: Adoption; Apidae; Applications Grants; Area; Arrhythmia; Autonomic nervous system; Bladder; Brain; Budgets; CBL gene; California; Cardiovascular system; Cerebral Palsy; Charge; Clinic; Clinical Trials; Communication; Communities; Congestive Heart Failure; Data; Devices; Diabetes Mellitus; Disease; Documentation; Education; Electrodes; Electronics; Endocrine; Engineering; Ensure; Ethics; Family; Feedback; Foundations; Funding; Goals; Grant; Healthcare Systems; Heart Atrium; Human; Hypertension; Implant; Incontinence; Institution; Intestines; Label; Los Angeles; Macular degeneration; Marketing; Medical; Menopause; Michigan; Monitor; Motor; Myocardial Infarction; Names; Nerve Pain; Obesity; Ohio; Pain; Peripheral Nerves; Persons; Process; Property; Research; Resources; Retina; Retinitis Pigmentosa; Running; Schedule; Scientist; Sex Functioning; Skeletal Muscle; Spinal Cord; Spinal Ganglia; Spinal cord injury; Stomach; Stroke; Synapses; System; Technology; Testing; Universities; bioelectricity; bioelectronics; body system; clinical application; design; disability; first-in-human; implant design; implantable device; innovation; interest; meetings; neuroregulation; novel; online community; open source; operation; patient population; pelvic organ prolapse; recruit; relating to nervous system; spasticity; spinal cord and brain injury; web site

The primary goal of this COSMIIC HORNET project is to enable the research field to not only have access to new implantable technology, but also, where possible, to establish the ability to modify and innovate around that implantable technology. In order to achieve this goal, it is absolutely necessary that the COSMIIC HORNET project is directly applicable to the bioelectronic research community and provides the appropriate resources. To achieve this, we have formed a team of over 30 experts in neural interface technologies and their clinical applications. This “Beekeeper Team” will provide administrative oversight for the project. A key feature of our Beekeeper core is that it has broad representation of the spectrum of clinical applications for our implantable open source neuromodulation technology. The long-term objective of this project is widespread use of the COSMIIC modules to develop new medical treatments for a wide range of applications. This requires a focus on early dissemination and sustainability. The administration of this project will therefore have the following three specific aims: Aim 1) Ensure the widespread utility of the novel modules. The beekeepers will provide feedback on novel designs early in the design process to ensure that the device specifications and modes of operation will serve a wide community of users. In conjunction with an external advisory board, the administrative team will also monitor progress on the scheduled project milestones. Aim 2) Evaluate the distributed resources for completeness and safe ethical use. The COSMIIC HORNET modules will be designed for use by research teams with strong engineering expertise, who must have a thorough understanding of the devices they will use. The Beekeeper team will evaluate design and regulatory documentation prior to distribution to the public Aim 3) Create a community of early adopters who can serve as a resource for others. Each beekeeper has a personal interest in using this technology for their own research. During the course of this project, they will lay the groundwork for that use at the end of three years through FDA communications and grant applications. Each of the application represented by the beekeepers has a larger community of scientists who may benefit from using these devices. Beekeepers will serve as an ambassador for these novel devices within that community and we will also support and incorporate additional users who wish to become early adopters. At the end of this project, the existing modules already in human use will be fully open-sourced including all regulatory communications. Novel designs will be complete, and well documented. There will also be an online community of users at a variety of stages of adoption.

这个COSMIIC HORNET项目的主要目标是使研究领域不仅具有 获得新的植入式技术，而且在可能的情况下，建立修改和创新的能力 围绕着植入式技术。为了实现这一目标，COSMIIC必须 HORNET项目直接适用于生物电子研究社区，并提供适当的 资源为了实现这一目标，我们组建了一个由30多名神经接口技术专家组成的团队， 其临床应用。这个“养蜂人小组”将为项目提供行政监督。 我们的Beekeeper核心的一个关键特征是它具有广泛的临床代表性， 我们的植入式开源神经调节技术的应用。长期目标是 该项目是广泛使用COSMIIC模块，为各种各样的疾病开发新的医疗方法， 应用.这就需要注重早期传播和可持续性。本项目的管理 因此，将有以下三个具体目标： 目标1）确保新模块的广泛实用性。养蜂人将提供反馈 在设计过程的早期就进行新颖的设计，以确保设备规格和操作模式 服务于广大的用户群体。与外部咨询委员会一起，行政团队将 并监测计划项目里程碑的进展情况。 目标2）评估分布式资源的完整性和安全的道德使用。宇宙 HORNET模块将设计为供具有强大工程专业知识的研究团队使用，他们必须 对他们将使用的设备有全面的了解。Beekeeper团队将评估设计并 向公众分发之前的监管文件 目标3：创建一个早期采用者社区，他们可以作为其他人的资源。每个养蜂人 有个人有兴趣将这项技术用于他们自己的研究。在这个项目中，他们 将在三年后通过FDA的沟通和拨款为该用途奠定基础 应用.养蜂人代表的每个应用程序都有一个更大的科学家社区， 可以从使用这些设备中受益。养蜂人将作为这些新设备的大使， 我们还将支持和吸纳更多希望成为早期采用者的用户。 在这个项目结束时，已经在人类使用的现有模块将完全开源 包括所有监管通信。新颖的设计将是完整的，并有据可查。也会 成为一个在线社区的用户在各种阶段的采用。