BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
Milestone-driven cooperative agreements fund translational development, verification/validation, IDE-enabling work, and small clinical studies for human CNS recording or modulation devices for nervous and neuromuscular disorders.
⚑ Cooperative agreement with NIH staff participation in project planning and progress monitoring · Milestone-driven award structure · Clinical trial optional · Foreign organizations are eligible, but non-domestic components of U.S. organizations are not eligible to apply as such
Unit fits — one characterization, each unit's own rules
| Physical Sciences & Engineering (demo) | 90 strong | technical depth: central; funds applied research |
| IPPRA | 58 good | peripheral portfolio topic: public_health; social/behavioral work is minor; funds applied research; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped) |
| Tom Love Innovation Hub | 45 partial | funds applied research; prototyping/demonstration stage; deep-tech content |
Description
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.
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · National Institutes of Health conventions SEE AN NIH EXAMPLE →
Funder-faithful document skeletons — National Institutes of Health's document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.