Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for investigators and institutions pursuing early clinical trials of novel recording and stimulation devices for central nervous system disorders. Eligible applicants include academic institutions, research hospitals, faith-based and community-based organizations, HBCUs, tribal colleges, and some federal agencies. The clinical trial must answer key design or functional questions that cannot be addressed through non-clinical testing alone. Activities include acute or short-term Non-Significant Risk (NSR) procedures, or longer-term Significant Risk (SR) studies requiring FDA Investigational Device Exemption approval.
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Program description
The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device.As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices’ existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
How to apply
Application links
Required documents
- SF-424 (R&R) application form
- Project Narrative
- Biosketch for PD/PI and key personnel
- Budget and budget justification
- Institutional Review Board (IRB) approval or evidence of IRB engagement
- FDA Investigational Device Exemption (IDE) documentation or NSR determination letter
- Device manufacturer commitment or MOU (if applicable)
- Letters of support from clinical site(s)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.866 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$463,372,200
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$172,327,224
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$115,145,694
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$99,649,073
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$93,275,174
-
$82,572,681
-
$81,344,612
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$78,657,309
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$75,825,492
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$75,398,895
Top States by Funding
- CA 10 awards $633.7M
- MI 2 awards $511.9M
- MO 8 awards $453.5M
- IN 4 awards $303.9M
- PA 6 awards $298.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.866). How funding has trended year over year.
| 2024 | $3,746,886,731 | |
| 2025 | $3,777,464,644 | |
| 2026 est. | $261,814,471 |
FAQ
Who is eligible to apply for this grant?
Academic institutions, hospitals, HBCUs, tribally controlled colleges, faith-based organizations, and some federal agencies may apply. Non-U.S. organizations are not eligible, though foreign components of U.S. organizations are allowed.
What types of clinical studies are supported?
The grant supports small clinical trials of recording or stimulation devices for CNS disorders. Studies can be acute/short-term NSR procedures or chronic Significant Risk studies requiring FDA IDE approval.
How does the BRAIN Public-Private Partnership help applicants?
The BRAIN PPP connects researchers with device manufacturers who provide devices for clinical research. Many devices have existing safety data, reducing the need for additional non-clinical testing before clinical trials.
What is the typical project duration and funding level?
This is a clinical trial grant from NIH with variable project lengths depending on study design. Consult the full FOA for specific funding ranges and timeline expectations.
What makes an application competitive?
Strong applications clearly demonstrate that the clinical trial answers critical design questions. Show existing device safety data and explain why non-clinical testing cannot address your research questions.
💡 Tips for applicants
- Clearly define the specific device design or function questions your trial will answer. Vague endpoints reduce competitiveness.
- Leverage the BRAIN PPP network early to secure device manufacturer commitments before writing your application.
- Demonstrate that your clinical questions cannot be answered through bench-top or animal studies alone.
- Include preliminary IRB or FDA correspondence showing the device pathway is feasible for your proposed trial.
- Budget realistically for small patient cohorts and the regulatory infrastructure needed for NSR or IDE studies.
⚠️ Common mistakes
Proposing trials that could be adequately answered through non-clinical testing or animal studies. Not securing device manufacturer support or commitment letters upfront. Underestimating regulatory timelines and IRB approval complexity for novel medical devices.
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- OPEN Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional) — National Institutes of Health
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