The goal of this Phase II Orphan Products project is to implement and evaluate the first multi-functional fully-implanted neuroprosthetic system for individuals with SCI. This study represents the first stage towards whole-body restoration of motor function for these patients. In this study, we will implant a novel modular neuroprosthetic system, the ?Networked Neuroprosthesis? (NNP), to provide grasp, reach, and trunk function for individuals with SCI at the C5 through C7 motor level. With this system, we propose that subjects will regain control over multiple functions, including grasp opening and closing, overhead reach, bed mobility, seated posture stability, and side-to-side reach. This study involves all aspects of the implementation, including the implanted technology, the surgical installation, and the outcomes assessment through a coordinated team approach in order to maximize the functional independence gained by the individual. The NNP system is the first fully implanted neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording and stimulating components. This eliminates the requirement of having to wear any external components taped to the skin in order to gain motor function, which has been a requirement of all motor neuroprostheses for SCI to date. The functional implications of this feature is numerous: the ability to utilize the neuroprosthesis during bathing and swimming, improved ability to control both the hand, arm, and trunk simultaneously, capacity to utilize the neuroprosthesis in the middle of the night, and the ability to use the stimulated functions without any donning assistance. We expect that these advances will lead to increased regular use of the neuroprosthesis, with a subsequent positive impact on quality of life.
This project is designed to develop and disseminate an advanced, fully- implantable neuroprosthesis for individuals with spinal cord injury. Individuals with both arms and legs paralyzed should regain grasping, reaching, and trunk movement as a result of neuroprosthetic intervention. The study is relevant to individuals with cervical level spinal cord injury because it provides them with the ability to use their hand, arm and trunk more independently. The study is relevant to all individuals with an orphan condition who would benefit from a medical device because the study establishes a new strategy for merchandising products where the market size is small and the investment in technology and support is relatively high.
