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

Closed Posted

Opportunity number
RFA-NS-25-022
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Categories
  • Education
  • Income Security and Social Services
  • Health
Eligible applicants
  • Public or Indian Housing Auth.
  • Non-501(c)(3) Nonprofits
  • Tribal Organizations (Not Federally Recognized)
  • 501(c)(3) Nonprofits
  • Small Businesses
  • Independent School Districts
  • State Governments
  • Higher Education Inst. (Public)
  • Tribal Governments (Federally Recognized)
  • County Governments
  • Higher Education Inst. (Private)
  • For Profit Organizations
  • City/Township Governments
  • Special District Governments
  • Other
Points of contact
Full announcement

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health is soliciting applications for clinical studies to advance next-generation recording and modulation devices for the central nervous system, with applications due September 28, 2026. This cooperative agreement opportunity supports Early Feasibility Studies and small clinical trials in device development for treating central nervous system disorders; eligible applicants include higher education institutions, nonprofit and for-profit organizations, small businesses, state and local governments, tribal entities, and other public or private institutions.

Applicants may pursue acute or short-term procedures determined Non-Significant Risk by an IRB, or Significant Risk studies requiring FDA Investigational Device Exemption approval, including chronic implants. The clinical trial must answer critical questions about device function or final design and generate data impractical to obtain through bench-top or animal studies alone. NIH's BRAIN Initiative Public-Private Partnership Program provides access to devices—including unapproved but clinically appropriate prototypes—from device manufacturers; existing safety and utility data for such devices are expected to support IRB or FDA approval without significant additional non-clinical testing.

Supported activities consist of small clinical trials designed to inform final device design in preparation for advanced clinical trials and market approval. Eligible applicants include public housing authorities, non-501(c)(3) nonprofits, federally and non-federally recognized tribal organizations and governments, 501(c)(3) nonprofits, small businesses, independent school districts, state and local governments, higher education institutions (public and private), for-profit organizations, city and township governments, and special district governments. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are ineligible; foreign components of U.S. organizations are permitted.

The funding opportunity is administered under multiple NIH institutes and centers: the National Institute of Mental Health, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Biomedical Imaging and Bioengineering, National Institute of Neurological Disorders and Stroke, National Institute on Aging, and National Center for Complementary and Integrative Health. The instrument is a cooperative agreement. The Assistance Listing numbers are 93.242 (Mental Health Research Grants), 93.273 (Alcohol Research Programs), 93.279 (Drug Use and Addiction Research Programs), 93.865 (Child Health and Human Development Extramural Research), 93.173 (Research Related to Deafness and Communication Disorders), 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), 93.213 (Research and Training in Complementary and Integrative Health), and 93.866 (Aging Research).

Synopsis

2 versions

Update #2 · Latest ·

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

Update #1 ·

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

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.

Files

File Type Posted
RFA-NS-25-022-Full-Announcement.html HTML file
PKG00288477.pdf PDF

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