Provide a brief description of the center and its focus. This is a CoE renewal application for the third grant period of the Advanced Platform Technology Center of Excellence from the Louis Stokes Cleveland VA Medical Center. The PI is Ron Triolo, a very experienced and well-funded investigator with awards from NIH (2), VA RR&D (2) and DOD (2) in addition to the current version of the Center. The proposed CoE is an infrastructure for translation and translational research in four main areas: Prosthetics/Orthotics Health Monitoring/Maintenance, Neural Interfacing and emerging Enabling Technologies. The CoE will predominantly fund the staff and some investigators, with support for research mainly occurring through leveraging grant and a modest pilot program. In each of these areas the CoE will work to move individual projects through the translational spectrum from basic science to proof of concept in animals to in vivo testing to in humans to clinical trials. As a result progres is made toward problems of great importance to the RR&D mission. There is great synergy in the local environment with the FES CoE, Case Western Reserve University and the Cleveland Clinic. The CoE investigators are leaders in the different research areas with more than $7 million in active funding for the current year. There is particular strength in prosthetics and neural interfacing. If funded, it is expected that a number of projects and technologies would be translated (or moved one step further along the translational continuum). The projects presented (the majority already funded by current active funding) are clearly feasible and well thought out. The previous funding cycle was exceptionally successful with CoE investigators receiving more the $58 million in external funding and the center becoming home to two PECASE awardees, six CDA recipients and two Senior Research Career Scientists as well as other senior investigators responsible for almost 250 publications, more than 330 presentations, 105 outreach and media events, and over 100 disclosures, 75 patent applications and licenses. Evaluation: Significance and Impact of Prior Work: The CoE has been incredibly productive (metrics given above) and has established a great working model, which has led to a number of promising translational research advances such as: * Determining the biocompatibility of novel nanocomposite material in rat cortex and developing new microfabrication techniques to process it into functional cortical recording probes, thus moving the project from proof-of-concept to initial pre-clinical testing. * Refining prototypes of wireless implanted bladder pressure monitor and modular surface electrotherapy system to test in vertebrate animals to prepare them for transition to first-in-man clinical feasibility trials * Filed a Device Master File for the FINE (flat interface nerve electrode), which was accepted by the FDA and referenced in two successful IDEs, enabling chronic human implantation for natural sensation to upper limb amputees and facilitate standing and stepping after paralysis. The devices have now been functioning without adverse event in amputees for more than two years. There are numerous additional examples of high impact research at various levels along the translational research continuum. Strength of Proposed Research Focus: The proposed work is highly relevant to the veteran population and it is certain that it will produce much new and useful information. The research focus areas have been defined very clearly and the high priority projects in each are detailed in such a manner that it seems very clear that the CoE will be able to execute the research projects successfully. There is much that will be contributed to the VA RR&D portfolio. One potential weakness is that several of the projects will contribute more to veteran health care than to rehabilitation practice as they are more general medical solutions. That being said, they are high impact projects that are able to use the developed infrastructure so this is at most a minor concern. Effectiveness of Operating Plan: This is a great strength of the proposal. The infrastructure that they are using has been proven to work. CoE funds support an outstanding professional support staff. They fund all or part of the following: regulatory affairs specialist, quality assurance specialist, engineering manager, director of external affairs and industrial relations, director of internal operations, information technology specialist, and various engineering staff (several supported entirely by research grants at the current time). Thus, most of the budget goes to professional staff to facilitate the success of the individual investigators to obtain extramural funding, which funds the research of the CoE. They will have a substantial impact with the overall VA research program as they are designed to be a national resource and collaborate with a number of different VA's beyond their local medical center and nearby CoE. They make their platform available to investigators nationwide. They also have developed a number of relationships with commercial businesses which will greatly facilitate the translation of their research to the VA and the rest of the healthcare community. Adequacy of Resources: The current VA RR&D program is exceptional. There are a large number of funded investigators with active VA and non-VA research funding (leveraged the CoE funding to $56 million to investigators over the last grant cycle). In addition there is strong support from the VA clinical investigators, VA administration and the academic affiliates. The scientific, engineering, or medical leadership of key personnel at the VA are outstanding. As noted previously, Dr. Triolo has an exceptional track record and record of current funding. Other investigators leading the various focus areas are also outstanding. The combination of VA resources and academic affiliate resources made available are also outstanding. Budget and Cost Effectiveness: The budget is able to support the program activities due to investigators being funded through VA Research Career Scientist awards or external research grant funding. The requested costs are reasonable. Additional Items: a. Protection of Human Subjects b. Inclusion of Women, Minorities, and Children c. Vertebrate Animals d. Biohazards All are acceptable. Summary Bullets: * Outstanding track record in previous grant periods and environment * Stellar PI and investigative team * Importance of proposed research areas to VA research program
The Advanced Platform Technology (APT) Center develops new restorative technologies that serve the unmet needs of disabled veterans, and translates them into clinical practice. We identify and harness recent advances in microelectronics, microfabrication, material science, and additive manufacturing to make original contributions to Prosthetics & Orthotics, Neural Interfacing, Health Monitoring & Maintenance, and Enabling Technologies. Over the next five years we will: 1) Translate original APT technologies to human feasibility trials, including a wireless implanted bladder pressure monitor, and systems to accelerate wound healing or provide natural sensation to amputees; 2) Perform definitive pre-clinical tests of new concepts, such as our miniature artificial lung and biologically active ventricular shunts and intracortical probes; 3) Increase interactions with industry to co-develop new technologies or conduct pivotal clinical trials; 4) Develop expertise in wireless communication and wearable sensors, and integrate it into Center products.
| Freeberg, M J; Stone, M A; Triolo, R J et al. (2017) The design of and chronic tissue response to a composite nerve electrode with patterned stiffness. J Neural Eng 14:036022 |
