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

The funding opportunity titled BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS is issued by the National Institutes of Health under the U.S. Department of Health and Human Services. It is part of the broader BRAIN Initiative, a federal effort launched in 2014 to accelerate the development of innovative neurotechnologies that enable a deeper understanding of brain function and ultimately support the treatment and prevention of neurological disorders. This program aligns with updated strategic frameworks including the BRAIN Initiative 2.0 vision, emphasizing interdisciplinary collaboration across neuroscience, engineering, computational science, and related domains. The primary purpose of this funding opportunity is to support the translation of novel technologies designed to record from or modulate the human central nervous system. Projects must begin at the proof-of-concept stage and progress toward readiness for first-in-human studies. The program encourages development of devices that may use electrical, optical, magnetic, acoustic, or hybrid modalities. Proposed work should focus on design-driven development rather than hypothesis-driven biological research, emphasizing prototype development, validation, and preparation for regulatory pathways. Funding supports a wide range of preclinical activities including device optimization, safety and effectiveness testing, software and firmware validation, and preparation for regulatory submissions such as FDA pre-submission meetings. Projects may also include development of associated tools, packaging, and system integration components. Clinical trials are explicitly not allowed under this opportunity. The maximum project period is three years, and applicants are expected to demonstrate a credible path toward human application within approximately five years of project completion. Eligibility for this program is broad and includes higher education institutions, nonprofits, for-profit organizations including small businesses, government entities at various levels, and tribal organizations. However, foreign organizations and non-U.S. components are not eligible to apply, although foreign components may be included in otherwise eligible U.S.-based applications. Multidisciplinary teams are strongly encouraged, and collaboration with industry partners is supported, often requiring documentation such as letters of support or collaborative research agreements. Applications must be submitted through Grants.gov using NIH systems such as ASSIST or institutional submission platforms. Required components include a research strategy, needs assessment, intellectual property strategy, team management plan, and a Gantt chart outlining project timelines. Additional required materials include detailed budget justification, data management and sharing plans, and supporting documentation for any collaborations. Letters of intent are encouraged approximately 60 days prior to submission but are not mandatory. Applications are evaluated based on NIH peer review criteria including significance, innovation, investigator qualifications, and approach. Additional emphasis is placed on the strength of the needs assessment, multidisciplinary team structure, and readiness for translation to human use. Reviewers also consider feasibility, regulatory strategy, and the robustness of development plans. Awards are expected to be announced following a two-stage review process involving scientific peer review and advisory council review. This opportunity operates on a recurring schedule with multiple submission deadlines each year through January 2027. Applications are due at 5:00 PM local time on specified dates, with advisory council reviews and project start dates following several months later. The program is expected to continue on a cyclical basis, supporting ongoing innovation in neurotechnology development under the NIH BRAIN Initiative.

Focus on design-driven development rather than hypothesis-driven research; demonstrate clear pathway to first-in-human studies; include strong multidisciplinary team and stakeholder input; provide quantitative benchmarks and regulatory strategy