Restoration of Grasp and Reach in Cervical Spinal Cord Injury

拟议的工作重点是恢复手和达到功能的人 颈部脊髓损伤对于遭受这种伤害的人， 手部功能的改善是他们的首要任务，现有的替代方案是有限的。神经假体是 最有前途的方法显着增益手和手臂的功能。 在这个CREATE项目中，我们建议通过以下方式为未来的关键临床试验做准备： 将第三代神经假体，网络神经假体，转移到两个临床 试验地点。这项工作将使临床培训计划的开发和评估成为可能， 建立器械可转移性的有效性，并为临床和患者带来有价值的 进入产品开发周期。这项工作是一个过渡步骤， 我们目前正在进行的早期可行性IDE经验，以及未来的临床试验 审判 在拟议工作的第一阶段，我们将加固植入式系统， 制造，并完成必要的验证和确认， 关键临床试验在第二阶段，我们将通过选择 并培训两个测试站点，以测试我们的培训材料和程序的可行性， 技术和医疗/外科手术的实施，以及我们的结果评价，在 以确定我们的系统是否准备好进一步转化为临床试验。 在这项工作之后，我们打算进一步扩大研究范围， 临床试验，以收集获得全面监管批准所需的确定性数据集， 市场发布，将使成功的商业化和更广泛的访问，为人们 脊髓损伤这一努力与可持续发展的总体战略相结合。 向SCI人群传播这项技术。因此，这项研究的影响不是 这只是为了证明单一临床应用的好处，但其影响也延伸到 通过建立一个可持续的， 实体，可以确保植入的神经假体的可用性，以个人谁可以 从中受益。

The proposed work is focused on restoration of hand and reaching functions for people with cervical level spinal cord injury. For individuals who have sustained this injury, restoration of hand function is their top priority, and existing alternatives are limited. Neuroprostheses are the most promising method for significant gain in hand and arm function. In this CREATE project, we propose to prepare for a future pivotal clinical trial by transfer of a third-generation neuroprosthetic, the Networked Neuroprosthesis, to two clinical trial sites. The effort will enable the development and evaluation of a clinical training program, establish the effectiveness of device transferability, and bring valuable clinical and patient experience into the product development cycle. The work represents an interim step between our Early Feasibility IDE experience which is currently underway, and a future Pivotal Clinical Trial. In the first phase of the proposed work, we will harden the implantable system for manufacture, and complete the verification and validation that will be necessary to perform a pivotal clinical trial. In the second phase, we will extend our Early Feasibility study by selecting and training two beta sites to test the feasibility of our training materials and procedures, our technology and medical/surgical procedures of implementation, and our outcome evaluations, in order to establish our system’s readiness for further translation to a Pivotal Clinical Trial. Following this work, our intent would be to undertake further expansion of the study to a Pivotal Clinical Trial in order to collect the definitive dataset necessary for full regulatory approval and market release that would enable successful commercialization and broader access for people with spinal cord injuries. This effort is coupled with an overall strategy for sustainable dissemination of this technology to the SCI population. Thus, the impact from this study is not only to demonstrate the benefits of a single clinical application, but the impact also extends to the entire field of SCI and similar orphan diseases through the establishment of a sustainable entity that can assure the availability of implanted neuroprostheses to the individuals who can benefit from them.