Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed) | PAR 25 286

Opportunity Information: Apply for PAR 25 286

This NIH grant opportunity (PAR-25-286) supports early-stage, high-impact projects to create the next generation of neuromodulation and neurostimulation devices aimed at treating mental health disorders. It uses the R21 mechanism, which is typically meant for exploratory and developmental work where investigators are building and de-risking bold new ideas rather than running large, definitive programs. A key boundary is stated up front: clinical trials are not allowed under this NOFO, so the work should focus on device innovation, engineering validation, preclinical testing, and other activities that move a technology forward without conducting a clinical trial.

The program is looking for two main kinds of projects. The first is the development of entirely novel brain stimulation devices, especially approaches that move beyond the usual electrical or magnetic stimulation paradigms. For these novel devices, the emphasis is on new stimulation techniques that can deliver better spatiotemporal precision (more accurate targeting in both space and time), enable multi-focal stimulation (coordinated stimulation of more than one site), and support closed-loop operation (systems that sense relevant signals and adjust stimulation in real time). The second type of project is a substantial upgrade to brain stimulation devices that are already FDA-approved or FDA-cleared, where the changes are meaningful enough to materially improve performance or therapeutic potential. The solicitation repeatedly signals that the improvements should be significant, not cosmetic.

In practical terms, the NOFO is steering applicants toward advances that clearly improve capabilities such as spatial resolution, depth of delivery, and precision. That means the device should be able to target brain circuits more accurately, reach structures that are harder to engage with existing tools, and deliver stimulation with tighter control and reproducibility. The announcement also clarifies what is not responsive: incremental changes, like minor software updates, are out of scope. The expectation is that applicants propose hardware and/or software improvements that amount to a real step-change in what the device can do, rather than routine iteration.

Because this is device development, the NIH is explicitly encouraging multidisciplinary teams. Competitive applications are expected to bring together expertise across systems neuroscience (to define and measure relevant neural targets and biomarkers), engineering (to design and build the device and its control systems), clinical knowledge (to ensure the approach is grounded in real mental health needs and realistic workflows), and regulatory affairs (to plan for eventual FDA pathways and compliance expectations). Even though clinical trials cannot be run within this award, the inclusion of regulatory expertise is a hint that NIH wants projects that are built with eventual translation and authorization in mind, not just laboratory demonstrations.

Eligibility is broad and includes many organization types. Domestic applicants can include state, county, city, and special district governments; independent school districts; public and state-controlled universities; private universities; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The notice also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, and certain non-U.S. entities (foreign organizations) and regional organizations. The funding agency is the National Institutes of Health, the opportunity falls under the health category (CFDA 93.242), and the listed original closing date is January 7, 2028.

Overall, the opportunity is best read as an NIH push to accelerate next-generation mental health neurotechnology by funding ambitious device concepts and substantial capability upgrades, while keeping the scope on development and validation rather than clinical efficacy testing. Applicants who can show a credible engineering plan, a strong neuroscience rationale, a clear path to materially improved stimulation performance (precision, depth, resolution, closed-loop and/or multi-site function), and an informed view of regulatory and translational requirements will be most aligned with what the NOFO is asking for.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2024-11-21.
• Applicants must submit their applications by 2028-01-07.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 286

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