Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional)
Can you apply?
This grant is for academic medical centers, research institutions, and universities interested in conducting NIH-funded research on neural circuitry and mental health disorders using invasive recording and stimulation techniques. Applicants must have institutional infrastructure, IRB approval capacity, and experience with clinical trial methodology. The R01 mechanism is open to nonprofit organizations, for-profit entities, state and local governments, and eligible foreign institutions. Domestically based organizations must have a U.S. location and valid tax status. Research activities must be compliant with federal regulations governing human subject research, institutional animal care, and biosafety. Geographic scope is not restricted; however, principal investigators typically hold positions at established research organizations.
This grant is for academic medical centers, research institutions, and universities interested in conducting NIH-funded research on neural circuitry and mental health disorders using invasive recording and stimulation techniques. Applicants must have institutional infrastructure, IRB approval capacity, and experience with clinical trial methodology. The R01 mechanism is open to nonprofit organizations, for-profit entities, state and local governments, and eligible foreign institutions. Domestically based organizations must have a U.S. location and valid tax status. Research activities must be compliant with federal regulations governing human subject research, institutional animal care, and biosafety. Geographic scope is not restricted; however, principal investigators typically hold positions at established research organizations.
Program description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate, via the same electrodes, allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for academic medical centers, research institutions, and universities interested in conducting NIH-funded research on neural circuitry and mental health disorders using invasive recording and stimulation techniques. Applicants must have institutional infrastructure, IRB approval capacity, and experience with clinical trial methodology. The R01 mechanism is open to nonprofit organizations, for-profit entities, state and local governments, and eligible foreign institutions. Domestically based organizations must have a U.S. location and valid tax status. Research activities must be compliant with federal regulations governing human subject research, institutional animal care, and biosafety. Geographic scope is not restricted; however, principal investigators typically hold positions at established research organizations.
How to apply
Application links
Required documents
- NIH Form 398 (R&R SF424 Application for Federal Assistance)
- Project Narrative (specific aims, significance, innovation, approach, and timeline)
- Detailed budget and budget narrative
- Biographical sketches of all key personnel (NIH format)
- Institutional support letters and resource sharing plans
- Institutional Review Board (IRB) approval or evidence of IRB review in progress
- Vertebrate animal assurance documentation (if applicable)
- Preliminary data and publications demonstrating feasibility
- Clinical trial protocol (if applicable)
- Letters of institutional commitment from collaborating sites
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 is eligible to apply for this R01 grant?
Research institutions, universities, medical centers, and organizations with 501(c)(3) status or equivalent. Applicants must demonstrate institutional capacity for human subjects research and clinical trial management.
What is the deadline for this grant?
The fixed deadline is January 7, 2028. Applications must be submitted by 11:59 p.m. ET on that date through Grants.gov.
What types of research activities are supported?
Studies using invasive neural recording and brain stimulation techniques to investigate neural mechanisms underlying mental health disorders. Research may include clinical trials in human subjects with appropriate safety and ethical oversight.
How competitive is this funding mechanism?
R01 grants are highly competitive. Success rates at NIH typically range from 10–25% depending on the institute or center. Strong preliminary data, innovation, and demonstrated track record significantly improve competitiveness.
What is the typical funding range for R01 grants?
R01 awards typically range from $250,000–$750,000 per year in direct costs, depending on the scientific scope and complexity. Total project periods usually span 3–5 years.
💡 Tips for applicants
- Develop robust preliminary data demonstrating feasibility of the proposed invasive recording/stimulation approach before submitting. Reviewers expect proof-of-concept evidence from pilot work.
- Clearly articulate the mental health disorder target and specify which neural circuits are hypothesized to be dysfunctional. Link your research directly to clinically meaningful outcomes and gaps in current understanding.
- Build a multidisciplinary team including neurosurgeons, neurophysiologists, psychiatrists, and biostatisticians to demonstrate comprehensive capacity to execute complex clinical research.
- Address ethical, safety, and regulatory considerations extensively in your protocol. Include detailed IRB approvals, informed consent procedures, and clinical monitoring plans for invasive procedures.
- Align your research with current NIH priority areas and review recent BRAIN Initiative awards to understand current funding priorities and demonstrate how your work advances the field.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary data on the invasive technique's feasibility and safety profile in the target population. Reviewers reject proposals that underestimate the complexity of clinical trial design or fail to address regulatory and ethical hurdles specific to invasive human procedures. Weak team composition—missing key expertise in neurosurgery, clinical trial methodology, or psychiatry—frequently undermines the scientific and operational credibility of applications.
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