The National Institutes of Health (NIH) is offering a funding opportunity through the BRAIN Initiative to support clinical studies aimed at advancing next-generation devices for recording and modulation in the human central nervous system. This initiative encourages small clinical trials, including first-in-human studies that require Investigational Device Exemption (IDE) approvals from the FDA, to gather critical data on the functionality and design of innovative devices intended to treat central nervous system disorders. The total anticipated funding is $10 million per year, with plans to award 5 to 7 grants over a project period not exceeding five years, and applicants must submit a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in research. Interested parties can find more information and application details at the NIH grants website, with the application deadline set for January 28, 2027.

RFA-NS-24-017-Full-Announcement.html

RFA-NS-24-017.html

The Department of Health and Human Services is issuing a Notice of Funding Opportunity (NOFO) through the National Institutes of Health (NIH) to support clinical studies focusing on innovative devices for recording and modulating the human central nervous system. This initiative is part of the BRAIN Initiative, aimed at advancing neurotechnologies to treat CNS disorders. The funding opportunity encourages first-in-human clinical trials necessitating Investigational Device Exemption (IDE) approvals from the FDA, aimed at obtaining crucial insights into the function and design of novel devices that cannot be garnered through non-clinical research methods.

Eligible applicants include a range of organizations, from educational institutions to for-profit businesses, and applications require a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity in research. The total funding anticipated is $10 million per year, expected to award 5 to 7 grants with a project period not exceeding five years. Milestone-driven projects under cooperative agreements require collaboration with NIH program staff for project oversight and success evaluation. Compliance with stringent application guidelines is mandated to ensure the quality and relevance of submitted proposals.

https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-017.html

Reissue: RFA-NS-21-024: The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require 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 (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices&apos; existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov

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

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