BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) | RFA NS 25 022

Opportunity Information: Apply for RFA NS 25 022

This NIH BRAIN Initiative funding opportunity (RFA-NS-25-022) supports small, focused clinical studies that move next-generation devices for recording from and/or modulating the human central nervous system closer to real-world clinical use. The central aim is to generate the kind of human data that is hard or impossible to obtain from additional benchtop testing or animal studies, especially when a device is novel or being used in a new way. Projects are expected to answer practical, decision-driving questions about how a device functions in people or what the final design should look like, so that the technology can advance toward larger clinical trials and, ultimately, pathways that could support regulatory clearance or approval and broader adoption.

The clinical work envisioned can range from acute or short-term studies to studies involving longer-term use, including chronic implants. The announcement makes room for both Non-Significant Risk (NSR) studies that an Institutional Review Board (IRB) can oversee without FDA IDE requirements, and Significant Risk (SR) studies that do require an Investigational Device Exemption (IDE) from the FDA. In other words, the program is set up to fund early feasibility-type clinical efforts where the goal is not a large pivotal trial, but a targeted, information-rich study that clarifies performance, safety considerations in context, usability, signal quality, stimulation effects, reliability, or other key attributes that directly inform the device design and next development steps.

A major feature of the opportunity is its connection to the NIH BRAIN Public-Private Partnership (BRAIN PPP). Through this program, NIH has established Memoranda of Understanding with multiple device manufacturers that are willing to provide devices and capabilities for clinical research, including some that are not yet market-approved but are appropriate for carefully designed clinical studies. The expectation is that many of these devices already have enough existing safety and utility data to support either a new NSR determination by an IRB or an IDE submission to the FDA without requiring large new packages of non-clinical testing first. This is meant to lower practical barriers and accelerate the transition from promising engineering to informative human testing, while still maintaining appropriate regulatory and ethical oversight. More information on the partnership is available at http://braininitiative.nih.gov/BRAINPPP/index.htm.

The funding instrument is a cooperative agreement (UH3), which generally means NIH staff will have substantial involvement during the project compared with a standard research grant. The activity category is listed under Education, Health, Income Security and Social Services, and the opportunity is administered by the National Institutes of Health. The emphasis is clearly on translational clinical data: the study should produce concrete results that help lock in a final or near-final device design and guide the remaining non-clinical work and subsequent clinical pathway, rather than exploratory work that could be done outside a clinical setting.

Eligibility is broad across U.S.-based organizations and includes state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The opportunity also explicitly highlights eligibility for a range of institution types and community-serving organizations, such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, faith-based or community-based organizations, and U.S. territories or possessions, among others. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined in the NIH Grants Policy Statement are allowed.

Key administrative details provided include an original closing date of 2026-09-28 and a creation date of 2024-11-05. The opportunity is listed with multiple CFDA (Assistance Listing) numbers, reflecting the cross-institute nature of BRAIN-related funding and the range of NIH programs that may be involved (93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867). The overall takeaway is that this announcement is designed for teams ready to put an advanced neural recording and/or stimulation technology into a carefully scoped human study to resolve critical uncertainties, finalize design choices, and accelerate a credible path toward the next stage of clinical and regulatory development.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2024-11-05.
• Applicants must submit their applications by 2026-09-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA NS 25 022

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