RFA-NS-25-022
BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
Summary
BRAIN Initiative: Clinical Studies for Next-Generation CNS Recording and Modulation Devices
Research Focus
This funding opportunity supports first-in-human or early-stage clinical studies of implantable or invasive devices designed to record from and/or stimulate the human central nervous system (CNS). The initiative targets Significant Risk (SR) devices requiring FDA Investigational Device Exemption (IDE) approval—typically chronic implants—to treat CNS disorders (neurological, psychiatric, sensory, developmental, or substance-use conditions) while advancing mechanistic understanding of brain function. Research must answer critical questions about device function, safety, or final design that cannot be resolved through non-clinical testing (bench-top or animal studies) alone due to device novelty. The BRAIN Initiative's Public-Private Partnership Program facilitates access to latest-generation Class III devices from manufacturers with existing safety and utility data, reducing barriers to clinical translation and leveraging manufacturers' non-clinical datasets to streamline FDA and IRB approvals.
At a Glance
- Who can apply: Academic institutions, research centers, businesses, and individuals developing devices or with established manufacturer collaborations; small businesses encouraged to apply to dedicated BRAIN Initiative small business NOFOs.
- Funding & project length: Not stated; UH3 phase (Phase II exploratory/developmental cooperative agreement).
- Award mechanism: UH3 cooperative agreement with milestone-driven oversight; participation in NIH BRAIN Multi-Council Working Group and mandatory PD/PI meetings required.
- Key dates: Applications due January 28, 2025 (earliest start September 28, 2026); expiration September 29, 2026.
- Best fit for: Neuroscientists, bioengineers, and clinicians conducting translational research on neural interfaces, brain-computer interfaces, or neuromodulation for disorders affecting vision, hearing, cognition, motor function, or substance use; interdisciplinary teams combining neuroscience, engineering, and clinical expertise.
Key Facts
Deadline
Mon, September 28, 2026
Posted
Tue, November 5, 2024
Keywords
Research Areas
Gotchas (3)
Only Significant Risk (SR) studies requiring FDA IDE are supported; studies requiring significant additional non-clinical testing are explicitly excluded
95%
Source Text
“Only Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants, will be supported by this NOFO... SR clinical studies in which a new IDE would require significant additional non-clinical testing but leverages existing company device data (these types of studies are not supported by this NOFO).”
Clinical study must provide data that cannot be practically obtained through non-clinical assessments due to device novelty; this is a prerequisite justification requirement
92%
Source Text
“The clinical study is expected to provide data to answer key questions about the function or final design of a device and is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.”
Mandatory participation in NIH-coordinated activities including PD/PI meetings and annual PI meeting is required as condition of award
90%
Source Text
“The BRAIN Initiative requires a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities such as the annual PI meeting.”