BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
Forecasted
This grant will fund early-stage clinical studies of new devices for recording or stimulating the human brain to treat neurological disorders and advance brain science, encouraging partnerships between researchers and device manufacturers.
Funder: National Institutes of Health
Due Dates (Anticipated): January 2027 (anticipated)
Funding Amounts: Estimated total program funding: $10,000,000; ~3 awards expected; cooperative agreement mechanism.
Summary: Supports first-in-human or early-stage clinical studies of next-generation devices for recording and/or modulation in the human central nervous system under the NIH BRAIN Initiative.
Description
This funding opportunity, offered by the NIH BRAIN Initiative, is designed to support first-in-human or early-stage clinical studies of innovative devices for recording and/or stimulating the human central nervous system (CNS). The goal is to accelerate the translation of next-generation neurotechnologies into clinical research, addressing both therapeutic and basic neuroscience questions. Projects may include studies of non-invasive (Non-Significant Risk, NSR) or invasive (Significant Risk, SR) devices, including those requiring an Investigational Device Exemption (IDE) from the FDA.
The program emphasizes milestone-driven research and encourages collaborations between clinical investigators and device manufacturers, facilitated through the NIH BRAIN Public Private Partnership Program. This aims to reduce barriers to partnership and leverage manufacturers' existing data to advance CNS device research. The clinical studies funded must generate data critical for understanding device function or informing final device design—data that cannot be reasonably obtained through further non-clinical (e.g., bench or animal) studies due to the device's novelty or intended use.
