Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 17, 2026
Can you apply?
This grant is for researchers and research institutions seeking to develop neuromodulation and neurostimulation devices for mental health applications. Eligible applicants typically include academic medical centers, research hospitals, biomedical device companies, and research-intensive nonprofit organizations with appropriate institutional infrastructure and IRB/regulatory oversight capabilities. The program supports early-stage and established investigators conducting device development research, but does not allow clinical trials in this mechanism. Geographic scope is U.S.-based researchers and institutions. The grant supports activities including device design and engineering, preclinical validation, proof-of-concept studies, and regulatory pathway planning for mental health therapeutic applications.
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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 withinthe scope of this announcement.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Application for Federal Assistance
- Project Narrative (12 pages maximum, typically includes aims, significance, innovation, approach, and timeline)
- Budget and Budget Justification (detailed direct/indirect costs)
- Biographical Sketch (for PI and key personnel)
- Preliminary Studies/Progress Report
- Letters of Support (from collaborators, clinical partners, regulatory advisors)
- Institutional Endorsement (from grants office and relevant department)
- NIH Form 424 Supplement (biosketches and other information)
- Data Management and Sharing Plan
- Vertebrate Animal Section (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
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$78,262,050
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$75,056,208
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$74,756,329
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$64,705,159
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$63,991,707
-
$54,214,022
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$48,653,752
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$38,895,082
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$38,475,557
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$35,940,675
Top States by Funding
- CA 15 awards $408.1M
- MA 9 awards $230.5M
- NY 6 awards $184.2M
- CT 4 awards $183.5M
- WA 4 awards $174.9M
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 is eligible to apply for this grant?
Domestic institutions, including academic medical centers, research hospitals, biomedical companies, and nonprofits with research capability. PIs must have appropriate training in neuroscience, engineering, or related fields. Clinical trials are not permitted under this mechanism.
What is the deadline and how often does it occur?
The deadline for this cycle is January 7, 2028 (fixed deadline). NIH R01 mechanisms typically have multiple deadlines per year; check the NIH funding opportunities page for future cycles.
What types of projects are funded?
Device development for mental health applications including neuromodulation and neurostimulation technologies. Projects should include device design, engineering, preclinical validation, and regulatory strategy. Clinical trials are not allowed.
How competitive is this funding mechanism?
R01 grants are highly competitive. Success rates for NIH R01s typically range from 15-25%. Preliminary data, innovation, and clear regulatory pathway planning are critical for competitiveness.
What is the typical funding range?
R01 grants typically fund $200,000-$500,000 per year for 4-5 years, though amounts vary by scientific area and institutional context. Direct costs are subject to NIH salary caps and institutional cost-sharing policies.
💡 Tips for applicants
- Develop preliminary data demonstrating proof-of-concept. NIH reviewers expect evidence that your device concept is technically feasible and addresses an unmet mental health need before funding.
- Build a multidisciplinary team including biomedical engineers, neuroscientists, and mental health clinicians. Reviewers favor applications showing strong collaboration across disciplines.
- Clearly articulate the regulatory pathway and FDA classification strategy early in the application. Demonstrate understanding of device classification, quality standards, and pre-market requirements.
- Focus your innovation on both device technology and the mental health application. Explain how your approach differs from existing neuromodulation devices and why the targeted condition requires this specific intervention.
- Include letters of support from collaborating institutions, clinical sites (for future studies), and regulatory consultants. External validation of feasibility and team expertise strengthens competitiveness.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary data or feasibility evidence to justify the proposed device development timeline. Reviewers reject proposals that read like basic neuroscience or clinical trial applications rather than focused device engineering efforts. Additionally, applications that underestimate regulatory requirements, fail to address intellectual property and manufacturing scalability, or propose overly ambitious timelines without staged milestones tend to score poorly.
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