Next-Generation Devices for Recording and Modulation in the Human CNS
Supports the development of next-generation neural devices for human neuroscience applications through collaborative research.
RFA-NS-25-021, administered by the NIH BRAIN Initiative with NINDS as lead Institute, funds UG3/UH3 two-phase cooperative agreements to develop next-generation devices for recording and modulating neural activity in the human central nervous system. The UG3 phase supports device development and engineering milestones, while the UH3 phase funds subsequent clinical studies in human subjects—advancement from UG3 to UH3 is contingent on meeting predefined go/no-go criteria. The cooperative agreement mechanism means NIH maintains substantial programmatic involvement throughout the project, distinguishing it from a standard investigator-initiated grant. A companion NOFO, RFA-NS-25-022, covers applicants entering directly at the UH3 clinical-studies phase.
Eligible applicants are U.S. universities and non-profit research organizations; for-profit companies and individual investigators are not eligible to apply as primary recipients. Registration and operations must be within the United States. Specific award dollar amounts were not captured in the structured record, but BRAIN neural-device cooperative agreements of this type have historically supported multi-year budgets commensurate with hardware engineering and first-in-human study costs.
To compete successfully, applicants should present a device concept that represents a step-change improvement in spatial resolution, channel count, biocompatibility, or chronic stability relative to current clinical systems. Review criteria will emphasize a credible path to human use, team expertise spanning engineering and clinical neuroscience, and a realistic milestone structure for the UG3-to-UH3 transition. Partnerships with academic medical centers capable of conducting the eventual clinical studies are strongly advantageous.
Funds UG3/UH3 two-phase cooperative agreements for developing and clinically translating next-generation devices for recording and modulating activity in the human central nervous system, led by NINDS.
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