Restoration of Grasp and Reach in Cervical Spinal Cord Injury

拟议的工作重点是恢复手和达到人的功能 颈椎水平脊髓损伤。对于遭受这种伤害的个人来说，恢复 手的功能是他们的首要任务，现有的选择是有限的。神经假体是 最有希望显著提高手和手臂功能的方法。 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 第三代神经假体，网络神经假体，转移到两个临床 审判地点。这一努力将使临床培训计划的开发和评估成为可能， 建立设备可转移性的有效性，为临床和患者带来有价值的 将经验融入产品开发周期。这项工作代表了 我们目前正在进行的早期可行性IDE体验，以及未来的关键临床 审判。 在拟议的第一阶段工作中，我们将强化植入式系统，以 制造，并完成必要的验证和确认，以执行 关键临床试验。在第二阶段，我们将延长前期的可行性研究，选择 和培训两个测试版网站，以测试我们的培训材料和程序的可行性，我们的 技术和医疗/外科程序的实施，以及我们在 以确定我们的系统是否准备好进一步转化为关键的临床试验。 在这项工作之后，我们的意图是将研究进一步扩大到一个关键的 临床试验，以收集完全监管批准所需的最终数据集 市场释放，这将使成功的商业化和更广泛的市场准入 有脊髓损伤。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 只是为了展示单一临床应用的好处，但其影响也延伸到 通过建立可持续的脊髓损伤和类似孤儿疾病的整个领域 一个实体，可以确保植入的神经假体可以提供给能够 从他们身上获益。

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.