Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed) | PAR 25 287

Opportunity Information: Apply for PAR 25 287

This funding opportunity, titled "Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)" (PAR-25-287), is a discretionary NIH grant program focused on pushing brain stimulation technology forward for the treatment of mental health disorders. The central goal is device development rather than running clinical trials, with an emphasis on building the next generation of neuromodulation and neurostimulation tools that can more precisely and effectively target brain circuits implicated in psychiatric conditions. The NOFO is explicitly aimed at meaningful technological advances that could change what these devices can do, not minor tweaks to existing products.

The opportunity supports two main types of projects. The first category is the development of truly novel brain stimulation devices that move beyond the standard electrical or magnetic stimulation approaches that dominate current practice. NIH is looking for new stimulation techniques that offer better spatiotemporal precision, meaning the ability to target smaller brain regions more accurately and to control stimulation in time with greater fidelity. Within this category, proposals that enable multi-focal stimulation (targeting multiple sites or networks rather than a single location) and closed-loop operation (where sensing and stimulation work together in a feedback system that adapts to the person’s brain state) are particularly responsive to the goals of the announcement. In practical terms, that points toward devices that can both measure relevant neural or physiological signals and adjust stimulation parameters in real time to optimize outcomes or reduce side effects.

The second category is for projects that significantly enhance the effectiveness of existing FDA-approved or FDA-cleared brain stimulation devices through substantial hardware and/or software improvements. The key word is significant: the NOFO draws a clear line between transformative upgrades and incremental changes. Straightforward or routine updates, such as small software revisions that do not materially expand device capability, are described as out of scope. Instead, NIH is looking for improvements that noticeably expand performance in areas like spatial resolution (stimulating more precisely), depth of delivery (reaching deeper targets noninvasively or more effectively), and overall precision (better control over where, when, and how stimulation is delivered). The intent is to fund development work that could meaningfully change treatment possibilities, including enabling more targeted engagement of neural circuits relevant to mental health.

Administratively, this is an NIH R01 grant mechanism and is designated "Clinical Trial Not Allowed," which signals that applications should not propose clinical trials as defined by NIH. Projects can still involve engineering development, benchtop validation, preclinical testing, and other non-clinical-trial human factors or feasibility activities as permitted under NIH policy, but the application must be structured to avoid a clinical trial component. The program falls under the Health activity category and is associated with CFDA number 93.242. The opportunity was created on 2024-11-21, and the listed original closing date is 2028-01-07. The award ceiling and expected number of awards are not specified in the provided source details.

Eligibility is broad and includes many types of domestic applicants, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (including those other than small businesses); and small businesses. It also includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as public housing authorities and Indian housing authorities. Beyond these standard categories, the NOFO also highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based or community-based organizations; regional organizations; U.S. territories or possessions; Indian/Native American Tribal Governments other than federally recognized; and non-domestic (non-U.S.) entities, meaning foreign organizations can also apply.

Overall, the opportunity is geared toward ambitious device-oriented R01 projects that can deliver a step change in neuromodulation capabilities for mental health applications, especially through new modalities, higher-precision targeting, deeper or more selective delivery, and closed-loop or multi-site stimulation strategies. The core message is that NIH wants engineering and technology development that materially advances the field, rather than incremental product refinement, and that proposals must be framed as development work rather than clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 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 25 287

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