BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
OpenDeadline: Sep 28, 2026federal
Updated: Oct 30, 2025
Summary
The grant aims to support small clinical trials that gather essential data for the development of recording and stimulating devices intended to treat central nervous system disorders and enhance understanding of the human brain. Eligible applicants include various government entities, nonprofit organizations, businesses, educational institutions, and specific minority-serving institutions. Application details are not explicitly provided in the description, but interested parties can contact NIH Grants Information for further inquiries.
Full Description
Description
The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial...
should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information 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. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device.As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm
Eligibility
Eligible applicants
Government
- Public and Indian housing authorities
- State governments
- Federally recognized Native American tribal governments
- County governments
- City or township governments
- Special district governments
Nonprofit
- Nonprofits non-higher education without 501(c)(3)
- Other Native American tribal organizations
- Nonprofits non-higher education with 501(c)(3)
Business
- Small businesses
- For-profit organizations other than small businesses
Education
- Independent school districts
- Public and state institutions of higher education
- Private institutions of higher education
Miscellaneous
- Other
Additional information
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.
Grantor contact information
Description
NIH Grants Information
grantsinfo@nih.gov
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Apply on official siteUpdated Oct 30, 2025
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