BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01 Basic Experimental Studies with Humans Required)

The National Institute of Neurological Disorders and Stroke (NINDS), in collaboration with several other Institutes and Centers of the National Institutes of Health (NIH), has announced its intent to publish a Notice of Funding Opportunity (NOFO) under the BRAIN Initiative. This initiative will focus on research that utilizes invasive neural recording and stimulating technologies in the human brain. The funding mechanism for this opportunity will be through a U01 cooperative agreement, specifically for basic experimental studies with humans. The announcement is currently a forecasted opportunity and applications are not yet being solicited, but the notice is being provided well in advance to allow potential applicants time to prepare and develop collaborations. The purpose of this opportunity is to enable researchers to conduct innovative studies that leverage direct intracranial access to investigate fundamental aspects of human neuroscience. By focusing on the unique ability to record and manipulate neural activity directly in the human brain, researchers can explore how the brain processes sensory input, memory, planning, decision-making, emotions, language, and movement. This research aims to advance the scientific understanding of the human brain in ways not possible through non-invasive or animal-based studies. Such insights may also inform future work on neurological disorders and contribute to therapeutic development. The NOFO encourages multidisciplinary collaboration. Investigators are expected to form teams that may include clinicians, neuroscientists, engineers, mathematicians, statisticians, data scientists, regulatory specialists, and ethicists. These teams will be encouraged to design research projects that are both scientifically rigorous and ethically sound, taking advantage of opportunities presented by surgical contexts where access to the human brain is possible. The overall scope of the funding is centered on advancing basic knowledge, not on immediate therapeutic applications, though the insights gained could have long-term relevance for treatment development. Eligibility for this program is broad, allowing applications from independent school districts, institutions of higher education (both public and private), state and local governments, county and township governments, tribal governments and organizations, nonprofit organizations with or without IRS 501(c)(3) status, for-profit organizations including small businesses, housing authorities, and special district governments. Additional eligible applicants include U.S. federal agencies, U.S. territories or possessions, faith-based and community organizations, regional organizations, and foreign institutions. This wide eligibility reflects NIH’s intent to draw from a broad pool of expertise and foster collaborations across sectors. The funding details, including award ceilings, floors, and total program funding, have not yet been specified in this forecast. The notice does confirm that cost-sharing or matching requirements will not apply. The official assistance listings associated with this program include 93.372 (21st Century Cures Act - Brain Research through Advancing Innovative Neurotechnologies) and 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The number of expected awards has not been provided at this stage. Funding is expected to begin with award notifications in November 2026 and project start dates in December 2026, aligned with fiscal year 2027. According to the forecast, the estimated posting date for the full NOFO is November 28, 2025, with an application due date of February 27, 2026. Awards are expected to be issued by November 1, 2026, with projects starting on December 1, 2026. Since this is a forecast, these dates are subject to change, but they provide applicants with a preliminary timeline for planning purposes. As the opportunity is listed under the NIH BRAIN Initiative, it is anticipated to recur on a regular basis, though the frequency has not been explicitly stated in the forecast. For inquiries regarding this funding opportunity, applicants are directed to contact Dr. Hermon R. Gebrehiwet, Dr.P.H., CCRP, who is listed as the grantor contact. He may be reached by phone at 240-328-8371 or via email at [email protected]. Potential applicants are encouraged to use this forecast period to begin assembling teams, preparing proposals, and building collaborations to ensure responsiveness to the forthcoming NOFO when it is formally released.