BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
Funding available for development of advanced devices to treat nervous system disorders through translational activities and small clinical studies.
Funder: National Institutes of Health
Due Dates: January 28, 2025 (New, Renewal, Resubmission, Revision) | September 28, 2026 (New, Renewal, Resubmission, Revision)
Funding Amounts: Up to $500,000 direct costs/year (UG3, 1 year) and up to $1,500,000 direct costs/year (UH3, up to 4 years); total project period not to exceed 5 years; NIH expects to fund 5–7 awards/year, $10M total/year.
Summary: Supports translational and small clinical studies to advance next-generation devices for recording and modulation in the human central nervous system, with a focus on regulatory and early clinical activities.
Key Information: Strict attachment requirements (Gantt chart, IP strategy, needs assessment, team management, long-term care plan); non-compliance leads to withdrawal. Only Significant Risk (SR) device studies requiring FDA IDE are eligible.
Description
This opportunity, part of the NIH BRAIN Initiative, funds translational and early clinical research to develop and test next-generation devices for recording and/or modulating activity in the human central nervous system (CNS). The program is designed to support regulatory activities (such as obtaining an Investigational Device Exemption [IDE] for Significant Risk [SR] studies) and subsequent small clinical studies that provide critical information about device function or design that cannot be obtained through non-clinical means. The program uses a milestone-driven UG3/UH3 cooperative agreement mechanism, with NIH staff actively involved in project planning and monitoring.
Projects must focus on a single CNS disorder or disease and are expected to be close to final device design or require early feasibility clinical data to inform final design. The program encourages integration of behavioral data streams and emphasizes data sharing, neuroethics, and patient long-term care planning.
