Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Optional) | PAR 18 942

Opportunity Information: Apply for PAR 18 942

This NIH funding opportunity (PAR 18-942) supports R01 grant applications focused on building the next generation of neuromodulation and neurostimulation devices aimed at treating mental health disorders. The central goal is device development that meaningfully advances how brain stimulation can be delivered for psychiatric indications, either by creating entirely new stimulation technologies or by making major, capability-changing improvements to devices that are already FDA-approved or FDA-cleared. While a clinical trial is allowed under this announcement, it is optional, so projects may range from advanced engineering and preclinical development through human testing when justified.

The FOA is looking for two broad types of projects. First, it invites truly novel brain stimulation devices that move beyond conventional electrical or magnetic stimulation approaches. These novel concepts are expected to offer substantial gains in spatiotemporal precision, meaning the ability to target the right brain areas with better accuracy in both space and timing. The FOA also explicitly encourages approaches that can stimulate multiple targets (multi-focal) and that can adapt stimulation in response to real-time signals (closed-loop systems). In practice, that means device concepts that can sense relevant neural or physiological activity, interpret it quickly, and automatically adjust stimulation parameters to optimize therapeutic effects and reduce side effects.

Second, the FOA supports projects that significantly enhance the effectiveness of existing FDA-approved or FDA-cleared brain stimulation devices through hardware and/or software improvements, but only when those changes represent a major functional upgrade rather than a minor refinement. Competitive proposals in this category would generally be expected to add new capabilities that matter clinically, such as substantially better spatial resolution (more selective targeting), greater depth of delivery (reaching deeper neural structures noninvasively or more effectively), and/or higher overall precision and control over stimulation delivery. The announcement makes it clear that incremental updates are out of scope; for example, a routine software update or a modest feature tweak that does not fundamentally change performance would not be considered responsive.

Administratively, this is a discretionary grant opportunity from the National Institutes of Health under the health activity category (CFDA 93.242). It uses the R01 mechanism, which typically supports well-scoped, hypothesis-driven or milestone-driven research and development programs that are ready for a substantial, multi-year effort. The original closing date listed for this particular posting was September 7, 2021, and the source text does not specify an award ceiling or expected number of awards.

Eligibility is broad and includes many types of organizations that can support device development work. Eligible applicants listed include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits both with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated); for-profit organizations other than small businesses; and small businesses. The FOA also calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations.

Overall, the opportunity is aimed at pushing the field beyond standard stimulation paradigms and toward tools that can more precisely engage relevant brain circuits for mental health treatment. The emphasis is on meaningful technological leaps: devices or major upgrades that improve targeting, depth, precision, and adaptability (including closed-loop control), rather than small, incremental revisions to what is already available.

• 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 Optional)" 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 2018-09-27.
• Applicants must submit their applications by 2021-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 18 942

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