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.
The goal of the proposed work is to restore grasp and reach for people with cervical level spinal cord injury by implementing a fully implantable neuroprosthesis. Through this work, the technology will be hardened for manufacture, training materials prepared for transfer to other centers, and patients will be enrolled at two beta clinical trial sites to set the stage for future pivotal trials. At the conclusion of the project, preparations will be complete for further expansion to a Pivotal Clinical Trial, in order to collect the definitive dataset necessary for full regulatory approval and market release.
