BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System

The BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System is a forecasted federal funding opportunity from the U.S. Department of Health and Human Services through the National Institutes of Health. The opportunity number is RFA-NS-28-006, and the funding instrument is a cooperative agreement in the Health category. The opportunity is associated with Assistance Listings 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 forecast anticipates approximately three awards and estimated total program funding of $10,000,000. The BRAIN Initiative, together with other NIH Institutes and Centers, intends to publish a Notice of Funding Opportunity encouraging investigators to pursue first-in-human or early-stage clinical studies involving recording and/or stimulating devices. The research is intended to advance devices used to treat central nervous system disorders and to improve understanding of the human brain. The planned opportunity will be milestone-driven and will involve collaboration with assigned program officers or directors, with joint responsibility for successful program management after award. Participation in the NIH BRAIN Initiative Public Private Partnership Program will be permitted. That program seeks to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and recording devices for clinical research involving the central nervous system. The planned clinical studies may involve Non-Significant Risk applications, including non-invasive devices, or Significant Risk applications requiring an Investigational Device Exemption from the U.S. Food and Drug Administration, including chronic implants. The clinical study is expected to generate data addressing key questions about device function or final design. The requested information should be information that cannot practically be obtained through additional non-clinical assessments, such as bench top or animal studies, because of the novelty of the device or its intended use. The forecast explains that safety and utility data for these devices can be costly to obtain and that this expense can create a substantial barrier to research progress. No cost sharing or matching requirement is identified. Eligibility is broad. Eligible applicants listed in the forecast include independent school districts; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status other than institutions of higher education; small businesses; city or township governments; county governments; special district governments; public and state controlled institutions of higher education; private institutions of higher education; state governments; for-profit organizations other than small businesses; federally recognized Native American tribal governments; and Native American tribal organizations other than federally recognized tribal governments. Additional eligible applicants include Indian or Native American tribal governments other than federally recognized governments, eligible agencies of the federal government, U.S. territories or possessions, faith-based or community-based organizations, regional organizations, and non-domestic entities or foreign institutions. No state-specific restriction is stated. Applications are not being solicited at this time. The notice is a forecast intended to provide potential applicants with sufficient time to develop meaningful collaborations and responsive projects before the formal Notice of Funding Opportunity is published. Because the source is only a forecast, it does not provide application questions, required proposal components, required uploads, pre-application gating requirements, or evaluation criteria. It also does not identify a letter of intent, concept paper, pre-proposal, or notice of intent deadline. Applicants therefore should rely on the future published Notice of Funding Opportunity for final submission requirements and review criteria rather than treating the forecast as an open solicitation. The forecast was issued September 10, 2026 and estimates that the opportunity will be posted December 10, 2026. The estimated application due date is January 28, 2027. The estimated award date is December 1, 2027, and the estimated project start date is also December 1, 2027. The fiscal year identified is 2028. No recurring schedule or future-cycle frequency is stated, so recurrence cannot be established from the source. No award ceiling, award floor, performance period, or archive date is provided. Questions regarding the forecast may be directed to BRAIN Initiative Devices through the NIH BRAIN Initiative program email at NINDS-Devices@nih.gov. No individual grantor contact name or telephone number is provided.

Develop meaningful collaborations and responsive projects before the NOFO is published; design the clinical study to answer key questions about device function or final design that cannot practically be answered through additional non-clinical assessments; consider applicable partnerships with manufacturers through the NIH BRAIN Initiative Public Private Partnership Program; prepare for milestone-driven collaborative program management after award.