BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)

The National Institutes of Health (NIH) is seeking applications for clinical studies to advance next-generation devices for recording and modulation in the human central nervous system. The goal of this initiative is to support the development of new devices and technologies that can be used to treat central nervous system disorders and better understand the human brain. • The clinical trials should provide data to answer key questions about the function or final design of a device. • The devices' existing safety and utility data should be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. • Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. • The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments. • The BRAIN Initiative has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements with device manufacturers willing to make such devices available for clinical research.