The National Institutes of Health (NIH) has announced a funding opportunity for clinical studies aimed at advancing next-generation devices for recording and modulation in the human central nervous system, under the BRAIN Initiative. This initiative seeks to support small clinical trials that provide critical data necessary for the development of devices intended to treat central nervous system disorders, particularly those requiring an Investigational Device Exemption (IDE) from the FDA. The funding is crucial for enhancing neurotechnology and improving treatment outcomes, with NIH planning to allocate approximately $10 million annually for 5 to 7 awards, each with a maximum budget of $1.5 million per year for up to five years. Interested applicants can find more information and submit inquiries via grantsinfo@nih.gov, with applications due by September 28, 2026.

RFA-NS-25-022-Full-Announcement.html

RFA-NS-25-022.html

The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) for clinical studies focused on next-generation devices to advance treatments for central nervous system (CNS) disorders. Specifically, this funding aims to support "Significant Risk" clinical studies that require an Investigational Device Exemption (IDE) from the FDA, focusing on recording and modulation devices. Projects must provide critical data that cannot be obtained through non-clinical assessments due to the novelty of the devices.

The initiative encourages diverse perspectives in research, advocating for transdisciplinary collaborations and participation from underrepresented demographics. NIH plans to allocate approximately $10 million annually for an estimated 5 to 7 awards, with a maximum budget of $1.5 million per year for each project, lasting up to five years.

Applicants need to submit detailed plans addressing technology translation, pending FDA communications, and a plan to enhance diversity. Milestones are a key aspect of project management, allowing NIH to monitor progress and make funding decisions. The application process requires comprehensive planning and collaboration among various stakeholders, with a strong emphasis on data sharing and addressing health disparities. This funding opportunity represents a strategic effort to advance neurotechnology and improve treatment outcomes for CNS disorders.

https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-25-022.html

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&apos; 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

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov

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

Buyer

Eligible Applicants

Funding Category

Funding Instrument

Opportunity Category

Cost Sharing or Matching Requirement

Original Source

Additional Information