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

This funding opportunity encourages investigators to pursue small clinical trials to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Clinical studies may consist of acute or short-term procedures deemed Non-Significant Risk (NSR) by an IRB, or Significant Risk (SR) studies requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements with device manufacturers willing to make such devices available, including devices not yet market approved but appropriate for clinical research.