BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS (R18 - Clinical Trial Not Allowed) | RFA NS 24 031

Opportunity Information: Apply for RFA NS 24 031

The NIH BRAIN Initiative funding opportunity "Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS" (RFA-NS-24-031) supports projects that push promising brain recording and neuromodulation technologies past early proof-of-concept and toward readiness for first-in-human (FIH) studies. The focus is specifically on the human central nervous system (CNS), with the practical goal of enabling new tools that can eventually help diagnose and/or treat neurological and neuropsychiatric diseases and disorders, while also improving fundamental understanding of how the human CNS works. This is an R18 grant mechanism and it explicitly does not allow clinical trials, so the work is meant to stay in the preclinical space while still being strongly translation-oriented.

Projects can involve essentially any signal modality used for neural recording or modulation, including electrical, optical, magnetic, acoustic, or hybrid systems that combine multiple modalities. In practice, this means NIH is open to a wide range of device and method concepts, as long as the application is aimed at advancing the technology toward a credible FIH trajectory. The program is trying to bridge the gap that often appears between a compelling laboratory demonstration and the level of engineering maturity, validation, and risk reduction needed before a technology is realistically ready to enter human testing.

A notable emphasis is on team-based, multidisciplinary applications. The solicitation encourages diverse groups that bring together the mix of skills required for translational neurotechnology, for example neuroscience, clinical domain expertise, electrical or mechanical engineering, materials science, signal processing, software, device fabrication, preclinical study design, safety and biocompatibility considerations, and planning for manufacturability and regulatory expectations. In other words, the program is not just looking for an interesting concept; it is looking for integrated development plans that address real-world constraints and demonstrate a path toward a device or system that could plausibly be used in humans after the preclinical package is complete.

In terms of applicants, eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The opportunity also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-U.S. (foreign) organizations are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components are allowed under NIH policy (as defined in the NIH Grants Policy Statement), meaning certain parts of the project may be carried out by foreign collaborators if they meet NIH requirements and are properly justified.

The award is offered as a discretionary NIH grant under CFDA program numbers that span multiple NIH institutes and centers (93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the cross-cutting nature of BRAIN Initiative neurotechnology development. The opportunity was created on March 19, 2024, and lists an original closing date of January 28, 2027. The listed award ceiling is $750,000. The posting also includes a field for expected awards, but no number is provided in the supplied source text.

Overall, this RFA is designed for applicants who already have an early demonstration of a novel CNS recording and/or modulation approach and now need focused support to do the rigorous preclinical development work that de-risks translation. The ideal application will read less like an open-ended research exploration and more like a structured technology development plan with clear performance goals and validation steps, aimed at producing a system that is genuinely positioned to move into first-in-human testing after the grant period, even though actual human clinical testing is not permitted under this funding mechanism.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS (R18 - Clinical Trial Not Allowed)" 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 2024-03-19.
• Applicants must submit their applications by 2027-01-28.
• Each selected applicant is eligible to receive up to $750,000.00 in funding.
• 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 24 031

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