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

National Institutes of Health

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue first-in-human or early stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Only Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants, will be supported by this NOFO. The clinical study is expected to provide data to answer key questions about the function or final design of a device and 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 NOFO is part of 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.

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 FDA IDE and IRB approvals without need for significant additional non-clinical data.

For more information on the BRAIN PPP, see https://braininitiative.nih.gov/research/neural-recording-modulation/public-private-partnerships-program .

Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to RFA-NS-25-021 or this NOFO.

Deadlines:

Letter of Intent: 60 days prior to receipt date
Application Due Date(s): Jan 28, 2025; Sep 28, 2026

RFA-NS-25-022 Expiration Date September 29, 2026

Specialties

Engineering and Physical Sciences

Medical - Basic Science

Medical - Translational

Medical

Medical - Clinical Science

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type: Government/Federal

Address: NA

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