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

The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative along with other NIH Institutes and Centers (ICs) intends to publish a Notice of Funding Opportunity (NOFO) to encourage investigators to pursue first-in-human or early-stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. This NOFO will be a part of a milestone-driven program, involving collaborative activities with the program officer(s)/director(s) assigned to the funded projects and joint responsibility for the successful management of the program post-award. This NOFO will allow participation in the NIH BRAIN Initiative Public Private Partnership Program which aims to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices to conduct clinical research in the CNS. Through the PPP, the BRAIN Initiative is interested in reducing barriers to negotiating such partnerships and ensuring that new clinical studies leverage manufacturers' existing data. Data demonstrating safety and utility of these devices are very costly to obtain and pose a substantial barrier to research progress.

Applications may be Non-Significant Risk (NSR), such as non-invasive devices, or Significant Risk (SR) requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical study is expected to provide data to answer key questions about the function or final design of a device and is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.