BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
This grant supports small clinical trials to advance next-gen devices for CNS recording and stimulation in humans, addressing neuro disorders and brain research.
Funder: National Institutes of Health
Due Dates: January 28, 2025 (New/Renewal/Resubmission/Revision) | September 28, 2026 (New/Renewal/Resubmission/Revision)
Funding Amounts: NIH anticipates $10M/year for 5–7 awards; budgets rarely exceed $1.5M direct costs/year; project period up to 5 years.
Summary: Supports first-in-human or early-stage clinical studies of next-generation devices for recording and/or stimulation in the human CNS to advance device development for CNS disorders.
Key Information: Only Significant Risk (SR) studies requiring FDA IDE are eligible; non-clinical testing must be complete before application.
Description
This NIH opportunity, part of the BRAIN Initiative, funds milestone-driven, first-in-human or early-stage clinical studies of next-generation devices for recording and/or stimulation in the human central nervous system (CNS). The goal is to generate critical data to advance device development for the treatment of CNS disorders and to improve understanding of the human brain. Supported studies must be Significant Risk (SR) clinical studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The program is designed to bridge the gap between non-clinical testing and larger clinical trials or market approval, supporting studies that cannot be addressed through further non-clinical (e.g., animal or bench) studies.
This opportunity is part of a broader NIH Public-Private Partnership Program (BRAIN PPP), which facilitates collaborations between clinical investigators and device manufacturers, including access to devices not yet market approved but appropriate for clinical research.
