Information on the Advanced Neural Prosthetics Research and Development

Background Information on the Advanced Neural Prosthetics Research and Development (U01) PA-09-063

What is the purpose of this program? The purpose of this cooperative agreement program is to encourage applications to pursue translational and pilot clinical studies for neural prosthetics. Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for clinical study, and proof-of-concept or pilot clinical studies.

What is a U01 cooperative agreement and what does it mean for this program? Cooperative agreements are a type of grant mechanism that allows more interaction than usual between the NIH and the awardee. U01s are often used in consortia and clinical trials. For this program, the NIH will be using the U01s to promote collaborations within the program and the neural prosthetics R&D community. In addition, NIH will have a significant role in the assessment of annual milestone performance.

Why do we have an Advanced Neural Prosthetics Program? This program replaces the long-standing and productive Neural Prosthesis Program (NPP) contract effort pursued by several NIH Institutes. The NPP supported both basic, translational, and in some instances clinical work in functional electrical stimulation for upper and lower extremity function, spinal cord stimulation, cortical prosthetics, etc. Instead of calling for specific research activities, this new program opens the door for investigator-initiated ideas and applications. Examples of R&D topics may include new brain machine/computer interface technologies, FES systems for restoration of a wide range of functions lost during paralysis, neural interfaces enabling prosthetic limb control. Regardless of stage of maturity, the neurotechnology should be on the path towards clinical application.

What kind of budgets should we expect to see? Up to $1M direct costs/year for 5 years.

What's different about these applications? Reviewers should expect to see a section called "Overall Plan for Neural Prosthetics Development" which should be a clearly stated project timeline that includes practical, achievable goals, and annual project milestones. These milestones should be based on quantitative criteria for success and should create go/no-go decision points for the project. For projects proposing clinical studies with invasive devices, you may see something about the FDA regulatory process referred to as "Design Control process" which makes use of "Design Inputs" that capture the needs of users (patients, clinicians, caregivers, customers). Please see the "Design Control Guidance For Medical Device Manufacturers" web page on the FDA web site for more information.

How do we review these applications? The standard review criteria are in place for this program. Please note that the applications may be less sensational new science and more nuts-and-bolts translational activities necessary to do pilot clinical work. Should a proposal be considered meritorious, NIH staff will negotiate the milestones with the PI and these will be part of the Notice of Award. Your input as a reviewer on the milestones will be highly valued in these negotiations.