09/09/2024 | Press release | Distributed by Public on 09/09/2024 14:46
In August, Kevin Kilgore, PhD, Staff Scientist in the Department of Physical Medicine and Rehabilitation (PM&R) at MetroHealth, received a formal notification about a grant award from the National Institutes of Health. Not once or twice, but 10 times over 10 consecutive days. The grants, which total $2.2 million for one year, will allow Dr. Kilgore and his team to significantly expand the work they began two years ago with a three-year, $12.5 million grant from the NIH.
Twenty years ago, the team - which also includes researchers from the University of Michigan and UCLA - began developing an implanted device, the Networked Neuroprosthesis (NNP), to help restore hand and trunk function in patients who have sustained a spinal cord injury (SCI).
As progress was made on the device, "We realized the implant itself could be useful for researchers around the world," said Dr. Kilgore, Professor in the Departments of Orthopaedics and PM&R at Case Western Reserve University and the MetroHealth Center for Rehabilitation Research.
The team decided to make all the plans for the device available under an open-source license, meaning that anyone could obtain the plans and the full rights to make the devices themselves, with modifications if they wanted.
Open-source software has been around since early days of software development. The development of 3-D printers enable the expansion of this idea to open-source hardware, but it's still less common than open-source software.
This is the first time anyone has tried to do this with a human implantable device, said Dr. Kilgore, the principal investigator.
The 2022 NIH grant was used to establish the Cleveland Open Source Modular Implant Innovators Community (COSMIIC), the first open source, modular network of active implantable devices for use in pre-clinical and early feasibility human research, and to provide ongoing support for this technology through a vibrant, sustainable community of users.
COSMIIC is comprised of a broad investigative team in Cleveland at Case Western Reserve, MetroHealth, the VA Northeast Ohio Healthcare System and the Cleveland Clinic Lerner College of Medicine. Also part of COSMIIC are investigators at the University of Michigan and the University of California, Los Angeles.
The recently awarded NIH grants will help researchers navigate the difficult and expensive regulatory process. Human implantable devices must go through the Food and Drug Administration in the U.S. and other regulatory organizations around the world. These new grants also establish new collaborations for use of the COSMIIC system at Case Western Reserve, University of Michigan and University of Wisconsin.
While much has been accomplished in the past two years, more needs to be done to ensure that the open-source community is sustainable for years to come, Dr. Kilgore said.
"This is an opportunity to give back to the research community and enable this to move forward a lot faster," he said. "We want to show how the implant system can be used for a variety of applications and has much broader use in the research community."