BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)

The BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed) is a funding opportunity issued by the U.S. Department of Health and Human Services through the National Institutes of Health (NIH), specifically involving several NIH Institutes and Centers. These include the National Institute of Neurological Disorders and Stroke (NINDS), along with additional participating organizations such as the National Eye Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, and others. The initiative is part of a broader effort to support transformative neuroscience research through the development of novel neurotechnologies aimed at capturing and manipulating neural activity with precision and scale. The primary goal of this Notice of Funding Opportunity (NOFO) is to solicit early-stage, proof-of-concept projects that address critical barriers in neuroscience experimentation, specifically those related to recording and modulating neural activity at cellular and circuit levels in the central nervous system (CNS). The emphasis is on high-risk, high-reward projects that may not yet have feasibility data but hold the potential to significantly advance the field if successful. The technologies developed under this opportunity should be compatible with use in behaving animals and validated in vivo. The initiative encourages multi-disciplinary integration of fields including biology, chemistry, physics, engineering, and computational sciences. Applicants are invited to propose development of instrumentation, devices, and associated software or molecular constructs for neural recording and manipulation. These technologies may utilize optical, electrical, magnetic, or acoustic modalities and must be aimed at understanding dynamic neural signaling across spatial and temporal scales. The NOFO specifically supports approaches that reduce costs, improve accessibility, and overcome existing experimental limitations. Examples of relevant innovations include miniaturized recording devices, multi-functional electrode arrays, and novel probes for real-time monitoring of neural activity or modulation states. Eligibility for this opportunity is broad and includes U.S.-based and foreign institutions of higher education, nonprofit and for-profit organizations, state and local governments, tribal entities, and certain public housing authorities. Foreign entities and components are also eligible. Applications are limited to new (not renewal or resubmission) and must not propose clinical trials. NIH strongly recommends applicants consult with scientific/research staff listed in the opportunity to ensure alignment with BRAIN Initiative goals before submission. Applications must be submitted electronically through one of three pathways: NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) platform. The earliest submission date is May 2, 2025, with multiple deadlines across 2025 and 2026. Applications are due by 5:00 PM local time on each due date. Key deadlines include June 2, 2025; January 20, 2026; and June 15, 2026. The maximum award period is three years, with no pre-defined budget limit, though budgets must align with project needs. A total of $10 million per year is expected to be available, funding approximately 15–20 awards annually. Evaluation of proposals will focus on three main factors: importance of the research, rigor and feasibility, and expertise and resources. Reviewers will consider how the proposed technology addresses current limitations, the novelty and potential impact of the approach, and the clarity of the validation strategy. Proposals must prioritize technology development rather than biological discovery, and should include resource sharing and data management plans. Following peer and advisory council review, selected awards are expected to begin as early as April 2026. The funding opportunity remains open until June 16, 2026, with anticipated recurring cycles based on historical patterns.

Focus proposal on early-stage technology development and in vivo validation; do not emphasize biological aims; ensure strong feasibility rationale and alternative strategies.