The loss of motor function due to neurological injury or disease has significant consequences on
independence, health, participation in society, and quality of life. Neurological disorders such as stroke,
cerebral palsy (CP), spinal cord injury (SCI) and multiple sclerosis (MS) can lead to loss of mobility and
significant loss of independence in daily activities. In many of these diseases, the motor system remains
intact but cortical control over these functions is lost. One method of restoring function to these individuals
is the use of electrical stimulation of the peripheral nerves, known as neuroprostheses, to restore
coordinated control of the paralyzed muscles. In order to address the needs of this patient population, a
new concept in neuroprostheses has recently been invented and developed at Case Western Reserve
University (CWRU). This neuroprosthesis is the “Networked Neuroprosthesis” (NNP), and uses a modular
approach to implanted devices. The NNP system is the first fully implanted modular neuroprosthesis that
includes implantation of all power, signal processing, biopotential signal recording, and stimulating
components. The modular design of the NNP System allows it to be configured and tailored for the needs
of each type of disability and each individual with a disability so that maximum use is made of the
individual's remaining voluntary function, with electrically-stimulated function provided as needed. A major
milestone of our program that has been achieved is the implantation of the NNP in the first subject. We now
seek to advance the technology to impact a broader patient population, improve users to access the
technology, and enable the transfer of the technology to the real-world clinical setting. To achieve these
goals, our Specific Aims are to 1) enhance the hardware, particularly through improved power management
and circuit upgrades; 2) improve software, with a focus on transfer of this technology to multiple sites; 3)
build completed systems, and 4) fully test all components in preparation for regulatory approval.
All proposed changes will be introduced to the FDA as modifications to the current design, and
appropriate regulatory approvals will be sought prior to advancing to clinical trials. At the end of this
proposal, we will have completed the full upgrade of the NNP System, greatly expanding clinical indications
and usability of the entire system. This work will culminate in the submission of an Early Feasibility IDE for
clinical implementation in SCI, establishing a beachhead for future studies.