Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed) | PAR 22 039

Opportunity Information: Apply for PAR 22 039

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number PAR 22 039 (CFDA 93.242). This announcement is a reissue of PAR-18-942 and is intended to push forward the next generation of brain stimulation technologies aimed at treating mental health disorders. It uses the R01 grant mechanism and specifically does not allow clinical trials, meaning the work should focus on device development and preclinical or non-clinical validation rather than testing interventions in human clinical trial designs.

The core goal of the FOA is to support projects that either create entirely new brain stimulation devices or make major, meaningful improvements to devices that are already FDA-approved or FDA-cleared. For novel devices, NIH is looking for approaches that go beyond conventional electrical or magnetic stimulation methods, with an emphasis on new stimulation techniques that can deliver better spatiotemporal precision. The opportunity also highlights interest in advanced system concepts such as multi-focal stimulation (targeting multiple brain regions or networks) and closed-loop approaches, where sensing and stimulation can be integrated so the device can adjust output based on real-time signals or biomarkers.

For teams proposing major enhancements to existing FDA-approved/cleared technologies, the FOA emphasizes that the improvements must be substantial and capability-expanding, not minor refinements. The announcement explicitly calls for development that significantly increases aspects like spatial resolution (more precise targeting), depth of delivery (reaching deeper structures effectively), and/or overall precision of stimulation. It also draws a clear boundary around what is not responsive: incremental changes to current devices, including simple software updates or similarly modest modifications, are considered outside the scope.

Eligibility is broad and includes many types of domestic organizations such as state, county, city/township, and special district governments; federally recognized Native American tribal governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education when categorized that way); for-profit organizations (other than small businesses); and small businesses. The FOA also notes additional eligible applicant categories, 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), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This structure is meant to encourage participation from a wide range of research, engineering, and translational development groups, including those serving historically underrepresented communities and those with specialized technical capabilities.

Operationally, the grant falls under the Health funding activity category and uses a standard grant funding instrument. The listing provided includes an original closing date of 2025-01-07 and a creation date of 2021-10-12. The award ceiling and expected number of awards are not specified in the provided source details, which often means applicants should consult the full FOA text and NIH institute/center guidance for budget expectations, project period norms, and program priorities. Overall, this opportunity is best suited for teams that can credibly demonstrate a pathway to a step-change improvement in neuromodulation technology for mental health applications, with a clear engineering and validation plan that is more ambitious than routine iteration but still grounded in feasible development milestones.

• 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 2021-10-12.
• Applicants must submit their applications by 2025-01-07. (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 22 039

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