This project involves research and development leading to the complete development of systems for FNS devices designed for subjects with high, middle, and low cervical injuries. This project will focus on the sufficiency of FNS in the restoration of coordinated upper extremity function movements such as hand grasp, pronation/supination, elbow extension and shoulder movement. To make the systems practical and attractive for use, the FNS system components will need to be made fully implantable, including sensors that provide the system and/or the user with sensory feedback and a paradigm for control. The contractor shall establish safety and feasibility of the proposed approach, the ability of the FNS system to synergistically control stimulated and voluntary movements, determine the most effective sensory and control components, and determine the quantitative metrics needed for testing system efficacy in restoration of upper extremity movements in human subjects. Spinal cord injury induces changes in muscle properties that vary between individuals based on the extent of denervation and disuse. Therefore, the following issues should be addressed: assessment of spasticity and the effects of muscle denervation, weakness, fatiguability and/or other complications on FNS system performance. While this contract does not constitute a clinical trial, it is expected that a sufficient number of human subjects will be enrolled in the study to enable statistical confidence in the findings, and establish appropriate inclusion/exclusion criteria and endpoints for planning definitive efficacy trials. A major goal of this effort is to enable transition to the commercial sector of technologies that can benefit disabled individuals. Consequently, a successful proposal will include a commercial transition plan for relevant milestones, deliverables, and accomplishments resulting from this effort.
