BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)

National Institutes of HealthAmount not specifiedClosed

Schools & universities Researchers Narrow eligibility

Deadline: Sep 28, 2026
Posted: Nov 5, 2024
Award amount: Amount not specified
Focus areas: Education Health Income Security and Social Services

In plain English

This NIH BRAIN Initiative program (UG3/UH3) is a milestone-driven cooperative agreement supporting translational development and small clinical studies of next-generation therapeutic and diagnostic devices for nervous and neuromuscular disorders. Eligible applicants are institutions, including minority-serving institutions, HBCUs, and tribal colleges; foreign organizations and foreign components of U.S. organizations are not eligible to apply, though foreign components are otherwise allowed. NIH program staff participate in project planning and monitoring. No award amount is stated; eligibility centers on research institutions able to develop and test devices.

AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.

Who can apply

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.

About this grant

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.

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