BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
ID: 356982Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Income Security and Social Services

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/356982

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-022.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity for clinical studies aimed at advancing next-generation devices for recording and modulation in the human central nervous system, under the BRAIN Initiative. This initiative seeks to support small clinical trials that provide critical data necessary for the development of devices intended to treat central nervous system disorders, particularly those requiring an Investigational Device Exemption (IDE) from the FDA. The funding is crucial for enhancing neurotechnology and improving treatment outcomes, with NIH planning to allocate approximately $10 million annually for 5 to 7 awards, each with a maximum budget of $1.5 million per year for up to five years. Interested applicants can find more information and submit inquiries via grantsinfo@nih.gov, with applications due by September 28, 2026.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-NS-25-022-Full-Announcement.html
    RFA-NS-25-022.html
    The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) for clinical studies focused on next-generation devices to advance treatments for central nervous system (CNS) disorders. Specifically, this funding aims to support "Significant Risk" clinical studies that require an Investigational Device Exemption (IDE) from the FDA, focusing on recording and modulation devices. Projects must provide critical data that cannot be obtained through non-clinical assessments due to the novelty of the devices. The initiative encourages diverse perspectives in research, advocating for transdisciplinary collaborations and participation from underrepresented demographics. NIH plans to allocate approximately $10 million annually for an estimated 5 to 7 awards, with a maximum budget of $1.5 million per year for each project, lasting up to five years. Applicants need to submit detailed plans addressing technology translation, pending FDA communications, and a plan to enhance diversity. Milestones are a key aspect of project management, allowing NIH to monitor progress and make funding decisions. The application process requires comprehensive planning and collaboration among various stakeholders, with a strong emphasis on data sharing and addressing health disparities. This funding opportunity represents a strategic effort to advance neurotechnology and improve treatment outcomes for CNS disorders.
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