BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
ID: 356981Type: 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/356981

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-021.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity under the BRAIN Initiative, aimed at advancing the development of next-generation devices for recording and modulation in the human central nervous system (CNS). This initiative encourages investigators to engage in translational activities and small clinical studies that focus on therapeutic and diagnostic devices for CNS disorders, particularly those requiring an Investigational Device Exemption (IDE) from the FDA. The program is structured in two phases: the UG3 phase for regulatory activities and the UH3 phase for conducting clinical studies, with a total project period not exceeding five years. NIH anticipates allocating approximately $10 million per year to fund 5 to 7 awards, with applications due by September 28, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-NS-25-021-Full-Announcement.html
    RFA-NS-25-021.html
    The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) under the BRAIN Initiative, aimed at fostering the development of next-generation devices for recording and modulation in the human central nervous system (CNS). This funding opportunity encourages investigators to advance translational activities and small clinical studies focused on treating CNS disorders, explicitly supporting projects that require an Investigational Device Exemption (IDE) from the FDA. The program is structured in two phases: the UG3 phase for regulatory activities and the UH3 phase for conducting clinical studies, with a total project period not exceeding five years. A Plan for Enhancing Diverse Perspectives (PEDP) is mandatory, promoting inclusivity within research teams and populations served. The NIH anticipates allocating approximately $10 million per year to fund 5 to 7 awards, with specific budget limits set for each phase. Eligible applicants include a variety of institutions and organizations, with instructions provided for the application process, milestone tracking, and regulatory compliance. As part of the broader goals of the BRAIN Initiative, this NOFO aims to accelerate the understanding and treatment of brain disorders through innovative technologies and collaboration with private sector partners.
    Similar Opportunities
    BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
    Active
    National Institutes of Health
    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.
    BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity under the BRAIN Initiative to support clinical studies aimed at advancing next-generation devices for recording and modulation within the human central nervous system (CNS). This initiative encourages proposals for early-stage clinical investigations, including first-in-human studies, that focus on treating CNS disorders and enhancing understanding of brain functions, particularly through Significant Risk studies requiring FDA Investigational Device Exemptions (IDEs) for chronic implants. The NIH plans to allocate approximately $10 million annually to fund 5 to 7 projects, emphasizing the importance of collaborations with device manufacturers through a public-private partnership program, and requires a Plan for Enhancing Diverse Perspectives as part of the application. Interested applicants can find more information and submit inquiries via grantsinfo@nih.gov, with the application deadline set for January 28, 2027.
    BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity under the BRAIN Initiative to support the development of next-generation devices for recording and modulation in the human central nervous system. This initiative aims to facilitate translational activities and small clinical studies focused on therapeutic and diagnostic devices for CNS disorders, particularly those requiring Investigational Device Exemptions (IDE) for significant risk studies. The program emphasizes milestone-driven cooperative agreements, collaboration among diverse research teams, and the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to promote equitable access in research. With an annual budget of $10 million available for approximately 5 to 7 awards, interested applicants can find more information and apply starting April 29, 2024, by contacting NIH Grants Information at grantsinfo@nih.gov.
    BRAIN Initiative: Optimization of Instrumentation and Device Technologies for Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "BRAIN Initiative: Optimization of Instrumentation and Device Technologies for Recording and Modulation in the Nervous System," aimed at enhancing technologies for recording neural activity and addressing significant challenges in neuroscience research. This initiative seeks applications focused on optimizing existing or emerging technologies through iterative testing with end users, with the goal of improving network recording capabilities and developing tools for circuit manipulation that can be validated in vivo. The funding, anticipated at $10 million per year for 15-20 awards, requires applicants to include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in research, with submissions due by January 20, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS (R18 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity under the BRAIN Initiative to support the development of innovative recording and modulation technologies for diagnosing and treating central nervous system (CNS) diseases. The initiative aims to advance technologies from proof of concept to readiness for first-in-human studies, encouraging diverse, team-based applications that integrate various domains of expertise. This funding opportunity, with an award ceiling of $750,000 and a total budget of approximately $8 million for 5-7 awards, requires applicants to submit a Plan for Enhancing Diverse Perspectives and several key attachments. Interested parties should note that the application submission period begins on April 29, 2024, and closes on January 28, 2027. For further details, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-24-031.html.
    BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System," aimed at advancing neuroscience research through innovative technology development. This initiative seeks applications for the creation of new hardware, software, or molecular constructs that address challenges in recording and modulating neural cells and circuits, with a focus on high-risk projects that could lead to transformative outcomes in understanding dynamic signaling within the central nervous system. The program allocates an estimated $10 million annually for 15-20 awards, emphasizing collaboration across scientific domains and encouraging participation from diverse institutions, particularly those supporting early-career researchers and underserved populations. Interested applicants should note that the application submission deadlines begin on May 2, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity under the BRAIN Initiative, titled "New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)." This initiative aims to support proof-of-concept testing and the development of innovative neurotechnologies that can enhance the understanding of brain circuit dynamics and facilitate transformative neuroscience research. The program encourages high-risk, high-impact projects that integrate diverse scientific domains and require applicants to submit a Plan for Enhancing Diverse Perspectives (PEDP) as part of their proposals. The total estimated funding available is $10 million annually, with plans to support 15-20 awards over a maximum project period of three years. Interested applicants must adhere to strict submission guidelines, and the application deadline is January 20, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    BRAIN Initiative: Optimization of Instrumentation and Device Technologies for Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the BRAIN Initiative, specifically targeting the optimization of instrumentation and device technologies for recording and modulation in the nervous system. This funding opportunity aims to enhance the understanding of neural circuits by supporting projects that utilize innovative technologies, such as optical, electrical, magnetic, or acoustic methodologies, to address significant challenges in neuroscience research. Successful proposals should demonstrate a commitment to interdisciplinary collaboration and include a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity among diverse teams and institutions. The initiative anticipates awarding approximately $10 million across 15-20 projects, with applications due by January 20, 2026. For further details, interested applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the official announcement at https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-017.html.
    BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Basic Experimental Studies with Humans Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity under the BRAIN Initiative for exploratory research using invasive neural recording and stimulating technologies in the human brain. This initiative aims to assemble diverse, multidisciplinary teams to investigate high-impact questions in human neuroscience, focusing on establishing feasibility and proof-of-principle for future invasive studies while addressing clinical and ethical considerations. The NIH plans to commit approximately $6 million to fund multiple awards, with each application budget capped at $700,000 for direct costs per year over a maximum project period of three years. Interested applicants can find more information and submit inquiries via email at grantsinfo@nih.gov, with the application deadline set for September 19, 2025.
    BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a federal grant opportunity under the BRAIN Initiative for New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21). This initiative invites applications focused on developing innovative technologies to enhance the recording and manipulation of neural activity, particularly at unprecedented scales, while emphasizing the importance of diverse perspectives in the research process. The program aims to advance neuroscience research by addressing critical areas in understanding neural circuits and their functions, with an estimated total program funding of $200,000 and an award ceiling of $200,000 per project. Interested applicants must submit their proposals by June 15, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.