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Closed on Sep 28, 2026

BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)

National Institutes of Health · Opportunity number RFA-NS-25-022

Details summarized from the official notice as of Sep 29, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.

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This opportunity is closed as of Sep 28, 2026. It is kept here for reference. See the related open opportunities below, or check the official listing in case the agency posts a new cycle.

Key facts

Opportunity numberRFA-NS-25-022
AgencyNational Institutes of Health
Department of Health and Human Services
Assistance listing (ALN, formerly CFDA)93.866, 93.867, 93.286, 93.279, 93.865, 93.853, 93.273, 93.173, 93.213, 93.242
PostedNov 5, 2024
DeadlineSep 28, 2026
Cost sharing or matching requiredNo
Funding typeCooperative agreement
CategoryEducation
Last updated hereSep 29, 2026

Summary from the notice

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

Who can apply

The official notice lists these applicant types as eligible:

  • Public and Indian housing authorities
  • Nonprofits without 501(c)(3) status (other than colleges)
  • Other Native American tribal organizations
  • Nonprofits with 501(c)(3) status (other than colleges)
  • Small businesses
  • Independent school districts
  • State governments
  • Public and state colleges and universities
  • Federally recognized tribal governments
  • County governments
  • Private colleges and universities
  • For-profit organizations other than small businesses
  • City or township governments
  • Special district governments
  • Others named in the notice (see the eligibility text)

Who should take a closer look

  • Small businesses
  • Nonprofits
  • Colleges and universities
  • State governments
  • Local governments
  • Tribal governments and organizations
  • Larger for-profit companies

Not listed as eligible

  • Individuals

Unless the eligibility text in the notice names you, this opportunity is probably not for you.

Eligibility details from the notice

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.

Registrations you will likely need

Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.

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