Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
Can you apply?
This grant is for developing next-generation brain stimulation devices to treat mental health disorders. Eligible applicants include colleges, universities, research institutions, nonprofit organizations, and federal agencies. Both domestic and foreign organizations may apply. The focus is on novel devices or significant enhancements to FDA-approved devices using new stimulation techniques or improved spatial/temporal precision. Multi-disciplinary teams with expertise in neuroscience, engineering, clinical work, and regulatory affairs are strongly encouraged.
This grant is for developing next-generation brain stimulation devices to treat mental health disorders. Eligible applicants include colleges, universities, research institutions, nonprofit organizations, and federal agencies. Both domestic and foreign organizations may apply. The focus is on novel devices or significant enhancements to FDA-approved devices using new stimulation techniques or improved spatial/temporal precision. Multi-disciplinary teams with expertise in neuroscience, engineering, clinical work, and regulatory affairs are strongly encouraged.
Program description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates)are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with a variety of expertise including systems neuroscience, engineering, clinical, and regulatory affairs.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for developing next-generation brain stimulation devices to treat mental health disorders. Eligible applicants include colleges, universities, research institutions, nonprofit organizations, and federal agencies. Both domestic and foreign organizations may apply. The focus is on novel devices or significant enhancements to FDA-approved devices using new stimulation techniques or improved spatial/temporal precision. Multi-disciplinary teams with expertise in neuroscience, engineering, clinical work, and regulatory affairs are strongly encouraged.
How to apply
Application links
Required documents
- NIH R21 grant application (SF-424 Research and Related Senior Key Person Profile)
- Project Narrative (per NIH guidelines)
- Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- Facilities and Resources
- Letters of Support (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.242 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$75,056,208
-
$74,756,329
-
$72,845,834
-
$64,705,159
-
$63,991,707
-
$54,214,022
-
$38,895,082
-
$38,475,557
-
$34,635,977
-
$34,475,710
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.3M
- NY 6 awards $184.2M
- WA 4 awards $174.9M
- CT 3 awards $138.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.242). How funding has trended year over year.
| 2024 | $1,722,300,004 | |
| 2025 | $1,726,864,191 | |
| 2026 est. | $99,221,272 |
FAQ
Who can apply for this grant?
Colleges, universities, research institutions, nonprofits, faith-based organizations, and federal agencies are eligible. Foreign organizations may also apply.
What types of devices are in scope?
Novel brain stimulation devices with new techniques, or significant enhancements to FDA-approved devices. Incremental software updates alone are not eligible.
What expertise should my team have?
Teams should include systems neuroscience, engineering, clinical, and regulatory affairs expertise. Multi-disciplinary collaboration is essential.
What is the deadline?
The fixed deadline is January 7, 2028. Check the NIH grants website for any updates before submitting.
Can international organizations apply?
Yes, non-domestic (foreign) organizations are explicitly eligible under this NOFO.
💡 Tips for applicants
- Emphasize novel stimulation techniques or significant hardware/software improvements, not minor updates. Clear differentiation from existing devices strengthens competitiveness.
- Assemble a genuinely multi-disciplinary team early. Include clinicians, engineers, neuroscientists, and regulatory experts to address all required perspectives.
- Detail how your device achieves increased spatiotemporal precision, multi-focal capability, or closed-loop functionality. These are key evaluation criteria.
- Address FDA regulatory pathway explicitly. Show understanding of what approvals your device will need and a realistic timeline.
- Pilot data demonstrating feasibility or proof-of-concept significantly strengthens applications. Include preliminary evidence wherever possible.
⚠️ Common mistakes
Proposing incremental changes to existing devices rather than truly novel approaches or significant enhancements. Submitting applications without multi-disciplinary team expertise in all required domains. Underestimating regulatory pathway complexity and FDA approval timelines in project planning.
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