Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Optional) | PAR 18 941

Opportunity Information: Apply for PAR 18 941

The Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Optional) funding opportunity (NIH, PAR 18-941; CFDA 93.242) supports early-stage, high-impact research aimed at building the next generation of brain stimulation technologies for treating mental health disorders. The core intent is device development rather than basic science alone, with an emphasis on advancing what brain stimulation can do in terms of how precisely, how deeply, and how adaptively it can modulate neural circuits relevant to psychiatric symptoms. The mechanism is an R21, which is typically used for exploratory, proof-of-concept work where strong innovation and feasibility are central.

The FOA invites two main types of projects. First, applicants may propose entirely novel brain stimulation devices that go beyond conventional electrical or magnetic approaches, especially those capable of higher spatiotemporal precision, multi-focal stimulation (targeting more than one brain region or network node), and closed-loop operation (where sensing and stimulation are integrated so the device can adjust stimulation based on measured neural or behavioral signals). Second, applicants may propose substantial enhancements to existing brain stimulation devices that are already FDA-approved or FDA-cleared, but only if the improvements are meaningful and enable new performance or clinical capabilities. The announcement is explicit that incremental tweaks, such as minor software updates or small iterative modifications, are not considered responsive; the expectation is a clear step forward in capability.

In practical terms, proposals should focus on major gains in one or more of the following: spatial resolution (more precise targeting), depth of delivery (reaching relevant structures more effectively), and overall precision (better control over stimulation parameters and their effects). Projects that add genuinely new functional capabilities, such as robust closed-loop control, multi-site coordination, or improved targeting that changes the clinical potential of a device, align well with the stated priorities. Because this is framed around mental health applications, applicants should be able to explain how the device capabilities connect to psychiatric treatment needs, including plausible targets, biomarkers, or circuit-level hypotheses that justify the engineering direction.

The FOA also signals that successful applications should come from multi-disciplinary teams. NIH is looking for groups that can cover the full pipeline needed for device development: systems neuroscience to define relevant circuits and signals, engineering to design and build the hardware/software, clinical expertise to ensure real-world relevance and eventual clinical integration, and regulatory affairs expertise to anticipate requirements for safety, testing, and potential future FDA pathways. The inclusion of regulatory competence is a notable emphasis, since device projects often stall when regulatory planning is not built in early.

The funding instrument is a discretionary NIH grant, and the FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that do or do not involve clinical trials, depending on what is appropriate for the stage of development. The opportunity is broadly open to a wide range of eligible applicants, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); and other organizations. It also explicitly highlights additional eligible 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 even non-U.S. entities (foreign organizations) and regional organizations, underscoring an intent to encourage broad participation.

Administratively, the agency is the National Institutes of Health, and the original posting information indicates a creation date of 2018-09-27 and an original closing date of 2021-09-07, with the award ceiling and expected awards not specified in the provided source. Overall, the opportunity is best understood as NIH support for ambitious, prototype-to-demonstration level work that can materially change the capabilities of neuromodulation for mental health, particularly through novel modalities and closed-loop, multi-target precision approaches, rather than minor iterative updates to existing tools.

• 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 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 18 941

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