BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you have a novel neural recording or modulation device ready to move from bench to human testing, this milestone-driven program funds the full path to early clinical validation.
Report stale or inaccurate summary
What this is
This NIH BRAIN Initiative program funds development of therapeutic and diagnostic devices targeting nervous system disorders. It supports the full translational pipeline: clinical prototype implementation, safety/efficacy testing, design verification, FDA Investigational Device Exemption (IDE) applications, and subsequent small clinical studies. Applicants must demonstrate that human testing is necessary to answer design or function questions that bench-top or animal work cannot resolve. This is a milestone-driven cooperative agreement with active NIH program staff involvement in project planning and monitoring.
Who can apply
Very broad: small businesses, nonprofits (501(c)(3) and non-501(c)(3)), universities, for-profits, government entities, tribal organizations, and others all eligible. No explicit size cap mentioned; requires ability to conduct rigorous non-clinical testing and manage FDA IDE pathway.
Eligible applicant types
- Public and State controlled institutions of higher education
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Special district governments
- Public housing authorities/Indian housing authorities
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- City or township governments
- Private institutions of higher education
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized tribal governments)
- State governments
- Small businesses
- County governments
- Independent school districts
- For profit organizations other than small businesses
Full description — from the agency
The purpose of this announcement is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study 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. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.
Topics: brain device · neuromodulation recording · clinical trial · medical device · nervous system · ide application · translational neuroscience
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.