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

Federal funding opportunity RFA-NS-25-022 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes September 28, 2026

Posted
November 5, 2024
Closes
September 28, 2026
Cost sharing
No
Instrument
Cooperative Agreement
Assistance listing
93.866, 93.867, 93.286, 93.279, 93.865, 93.853, 93.273, 93.173, 93.213, 93.242
Category
Education, Health, Income Security and Social Services
Archives
November 3, 2026

Program funding history

Awards made under Assistance Listing 93.866 across FY2024–FY2026, from public federal spending records.

FY2024 obligated
$3.8B
FY2025 obligated
$3.9B
FY2026 (to date) obligated
$1.7B
Awards in window
11,903

Top recipients: Regents of the University of Michigan, Regents of the University of California, San Francisco, the, The Trustees of Columbia University in the City of New York, Washington University, the, University of Southern California

Source: USAspending.gov · refreshed July 2026

Synopsis

The purpose of this announcement 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' 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

Who can apply

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source.

View on Grants.gov   Full announcement

Agency contact: National Institutes of Health · grantsinfo@nih.gov · 301-402-2541

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