Spinal Cord Injury
Efficacy Study of a Fully Implanted Neuroprosthesis for Functional Benefit to Individuals with Tetraplegia
Posted September 2, 2020
P. Hunter Peckham, Ph.D., Case Western Reserve University
Dr. P. Hunter Peckham
Individuals with mid-cervical level spinal cord injuries (SCI) have few options available to improve hand function. Current available products typically provide limited gains, and individuals often require multiple pieces of equipment to perform daily tasks. Upper extremity neuroprostheses, which use electricity to activate peripheral nerves that contract muscles, have been shown to restore function for users; however, the devices require bulky external components, and the companies that manufacture the devices often stop production due to the limited market size.
With support from a Fiscal Year 2013 Clinical Trial Award from the Spinal Cord Injury Research Program, Dr. Hunter Peckham at Case Western Reserve University initiated a Phase II clinical trial to evaluate the safety and efficacy of a third-generation neuroprosthetic device, the Networked Neuroprosthetic (NNP) System. Dr. Peckham aims to both design a device that improves multiple aspects of a user’s quality of life and create a sustainable marketing and distribution strategy that will allow for continued availability of neuroprostheses to individuals with SCI.
Photograph of the Implantable NNP System components
The NNP System is the first neuroprosthesis that does not require external components to function. It is a fully modular network of implantable components that allows for coordinated control and activation of nerves in any region of the body. To date, the NNP System has been successfully implanted into five patients with SCI. Of those five, three have had their hand function fully evaluated post-implantation. The three patients that were fully evaluated showed substantial improvements after the device was implanted.
Additionally, all subjects reported gains in their ability to complete certain tasks, such as eating with a fork, picking up finger foods, writing, and opening doors. Improvements in posture, reach, and wheelchair propulsion were also observed. Individuals implanted with the hand and trunk modules had greater improvements in hand function and trunk stability than when either module was implanted alone. Daily usage rates of the NNP System were observed to be higher compared to previous neuroprosthetic systems, confirming the utility and importance of the device for individuals with SCI.
In 2016, the NNP System was accepted into the US Food and Drug Administration’s Expedited Access Pathway, which was created for devices that are innovative, address an unmet clinical need, and are in patients’ best interest. Dr. Peckham and his team have established a non-profit organization, the Institute for Functional Restoration (1), based at Case Western Reserve University that will facilitate the production, distribution, and deployment of neuroprosthetic systems for orphan patient populations, beginning with the NNP System and SCI.
A research subject demonstrates the use of the implanted NNP system. The Veteran is shown reaching his arms up above his head. He has a C5 spinal cord injury and, without stimulation, is unable to lift his arms above a few inches over his wheelchair arms. In the picture, he has the NNP trunk stimulation on, along with triceps stimulation, which allows him to reach overhead and reach side-to-side.
Dr. Peckham has demonstrated the potential of the NNP System to significantly impact the lives of individuals with SCI. Future research will focus on expanding the clinical applications of the NNP System after SCI by creating a multi-function device that will mediate hand function, trunk support, and cough and bladder function. Additional modules and sensors will be developed that will lead toward improved quality of life and independence for individuals with SCI.
Link:Public and Technical Abstracts: Efficacy Study of a Fully Implanted Neuroprosthesis for Functional Benefit to Individuals with Tetraplegia
Last updated Wednesday, September 2, 2020