BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) | RFA NS 24 017

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is an NIH BRAIN Initiative funding opportunity (RFA-NS-24-017) that supports small, device-focused clinical studies intended to move next-generation technologies for recording from and/or modulating the human central nervous system closer to broader clinical testing and eventual clinical use.

What is the main purpose of the program?

The purpose is to fund an early, tightly scoped clinical study (often comparable to an Early Feasibility Study) that generates specific human data needed to answer practical questions about how a novel neural device works in people and what changes are needed before larger trials or commercialization pathways can proceed.

What kinds of technologies does NIH want to support under this FOA?

The FOA focuses on next-generation neural technologies that record from and/or modulate the human central nervous system. The emphasis is on devices where human study data will directly inform device function and/or final device design.

Is this meant for large clinical trials?

No. The FOA is centered on intentionally small but highly informative clinical studies. The goal is to produce decision-quality data that materially shapes engineering and design decisions rather than to run large, confirmatory trials.

What is meant by a "device-focused" clinical study in this context?

A device-focused study is designed to answer practical, engineering-relevant questions such as device configuration, intended use, performance specifications, stimulation/recording parameters, usability considerations, and safety approaches for the next iteration of the system.

Are both acute and chronic implant studies allowed?

Yes. The FOA allows studies ranging from acute or short-term procedures to Significant Risk studies, including situations involving chronic implants, depending on the risk determination and regulatory requirements.

Can the study be Non-Significant Risk (NSR) or Significant Risk (SR)?

Yes. Studies may range from those an IRB determines to be Non-Significant Risk (NSR) to Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).

When is an FDA IDE relevant for projects under this opportunity?

An FDA IDE may be required for Significant Risk (SR) device studies. The FOA explicitly includes SR studies that require an IDE, including those involving chronic implants.

What is the key requirement about why human data is needed?

A central requirement is that the clinical study should produce information that cannot realistically be obtained through additional non-clinical work alone. If bench testing, simulations, or animal studies could adequately answer the question, that project is not the best fit for this program.

What kinds of questions should the human study data answer?

The FOA emphasizes targeted evidence that directly informs device function and/or design, including how the device operates in people, how it should be built or configured, what design changes are necessary, and what parameters and safety approaches are appropriate for the next development stage.

What does NIH mean by "de-risking" the technology?

In this FOA, de-risking means using human data to reduce uncertainty about device performance, use in real clinical settings, and remaining design unknowns that block progress toward more advanced clinical trials and eventual market approval activities.

What funding mechanism is used?

This opportunity is offered as a cooperative agreement (UH3), which generally indicates substantial NIH staff involvement during the project, consistent with cooperative agreement mechanisms.

What does "substantial NIH involvement" typically imply here?

Because the award is a UH3 cooperative agreement, NIH staff are expected to have substantial involvement in the project. Applicants should be prepared for an engaged NIH role during execution, consistent with the cooperative agreement structure.

The FOA says "clinical trial optional" - does that mean a clinical trial is not needed?

The FOA is described as "clinical trial optional," but it is framed around enabling a small clinical study when that is the critical next step. In practice, the program is geared toward applicants who can justify that a human study is essential to resolve key device questions.

What should applicants be ready to include in their plan?

Applicants should be prepared to present a credible clinical, regulatory, and engineering plan showing how the proposed study will produce decision-quality data for device advancement. The FOA highlights the importance of clear milestones and endpoints tied to device design questions rather than broad exploratory clinical hypotheses.

What are milestones and endpoints expected to be tied to?

Milestones and endpoints are expected to connect directly to device design and development questions (for example, parameter selection, usability constraints, performance specifications, or safety approaches), not broad or purely exploratory clinical hypotheses.

How is this FOA connected to the BRAIN Initiative Public-Private Partnership Program (BRAIN PPP)?

The FOA is linked to the BRAIN Initiative Public-Private Partnership Program (BRAIN PPP). Through Memoranda of Understanding with participating device manufacturers, investigators may be able to access advanced devices and capabilities for clinical research, including systems that are not yet market approved.

Can investigators access devices that are not market approved?

Potentially, yes. Through BRAIN PPP Memoranda of Understanding with participating device manufacturers, investigators may be able to access advanced systems that are not yet market approved but are appropriate for clinical research.

Does the FOA expect extensive new preclinical testing for PPP devices?

The FOA notes an expectation that existing safety and utility data for devices accessed through the PPP will often be sufficient to support either an IRB NSR determination or FDA IDE clearance for the proposed study, without requiring a large amount of new preclinical testing.

What is the benefit of the PPP element of this opportunity?

The intended benefit is to shorten the path to first-in-human or early-in-human learning when a device is mature enough to justify that step, by leveraging advanced devices and existing safety/utility data.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH), under the NIH BRAIN Initiative.

Is this a new program or a continuation?

This announcement is described as a reissue of an earlier announcement (RFA-NS-21-024), signaling continuity in NIH priorities around translating cutting-edge neurotechnology into human studies.

What types of organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations and includes public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and multiple levels of government (state, county, city/township, and special districts), as well as tribal governments and tribal organizations.

Does the FOA specifically encourage applications from certain institution types?

Yes. The FOA explicitly highlights inclusion of organizations such as HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions, along with faith-based or community-based organizations and U.S. territories or possessions.

Are non-U.S. (foreign) organizations eligible to apply?

No. Non-U.S. (foreign) organizations are not eligible to apply.

Can a U.S. organization include non-U.S. components?

No. Non-U.S. components of U.S. organizations are not eligible under this opportunity, based on the information provided.

Are any foreign activities allowed at all?

Possibly. The FOA notes that foreign components (as defined by NIH policy) may be allowed. This generally means discrete project elements could be performed abroad if justified and permitted under NIH rules.

What is the application window or closing date mentioned?

The original closing date is listed as January 28, 2027, suggesting a long application window. Applicants should still check the full FOA for specific receipt dates, cycles, and any updates.

Are there specific receipt dates within the overall window?

The information provided notes a long window through January 28, 2027, but also indicates applicants should consult the full FOA for specific receipt dates and cycles.

What program areas or assistance listings are associated with this FOA?

The FOA lists CFDA/assistance numbers spanning several NIH neuroscience and neurological disorder-related programs, reflecting the cross-cutting nature of the BRAIN Initiative and the broad relevance of device-based approaches for understanding brain function and treating CNS disorders.

What makes a project a strong fit for this FOA based on the description?

A strong fit is a small, tightly scoped human study that produces targeted evidence that directly informs device function and/or final device design, especially where human neuroanatomy, human behavior, novelty, or real-world clinical constraints make human data essential to resolve remaining uncertainties.

What types of outcomes does NIH want from funded studies?

NIH is looking for outcomes that materially shape engineering decisions and next-step development, such as changes to design, configuration, intended use, parameter choices, performance specifications, usability considerations, and safety approaches that prepare the device for more advanced clinical testing and eventual clinical use.