Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 20, 2026
Can you apply?
This grant is for biomedical researchers and clinical investigators developing novel neurotechnology devices for human brain recording and stimulation. Applicant organizations must have the capacity to conduct clinical studies in humans, institutional review board (IRB) approvals, and ability to partner with device manufacturers. Both first-in-human and early-stage clinical trials are eligible.
Applications may involve Non-Significant Risk (NSR) devices like non-invasive recordings, or Significant Risk (SR) devices requiring FDA Investigational Device Exemption (IDE) approval. Collaborative partnerships between research institutions and manufacturers are strongly encouraged through the NIH BRAIN Public Private Partnership program.
Only applications addressing central nervous system disorders with scientific merit and feasible clinical study designs will be considered. No cost sharing is required.
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Key dates
- Sep 10, 2026 Applications open
- Jan 28, 2027 Application deadline in 99 days
- Dec 1, 2027 Award announced
- Dec 1, 2027 Project start
Program description
The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative along with other NIH Institutes and Centers (ICs) intends to publish a Notice of Funding Opportunity (NOFO) to encourage investigators to pursue first-in-human or early-stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. This NOFO will be a part of a milestone-driven program, involving collaborative activities with the program officer(s)/director(s) assigned to the funded projects and joint responsibility for the successful management of the program post-award. This NOFO will allow participation in the NIH BRAIN Initiative Public Private Partnership Program which aims to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices to conduct clinical research in the CNS. Through the PPP, the BRAIN Initiative is interested in reducing barriers to negotiating such partnerships and ensuring that new clinical studies leverage manufacturers’ existing data. Data demonstrating safety and utility of these devices are very costly to obtain and pose a substantial barrier to research progress.
Applications may be Non-Significant Risk (NSR), such as non-invasive devices, or Significant Risk (SR) requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical study is expected to provide data to answer key questions about the function or final design of a device and is expected to provide information about the device function or final design 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. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative/Research Plan
- Budget and Budget Justification
- Institutional Review Board (IRB) approval or commitment letter
- FDA regulatory pathway documentation
- Letters of commitment from device manufacturer partners (if applicable)
- Curriculum vitae of key personnel
Program contact
- 👤 BRAIN Initiative Devices
- 📧 NINDS-Devices@nih.gov
- 📞 Please contact via e-mail.
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$56,262,774
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$45,083,283
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$43,730,658
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$38,186,781
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$37,769,493
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$35,655,349
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$35,655,116
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$34,183,297
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$32,294,153
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$32,164,022
Top States by Funding
- MA 7 awards $186.3M
- CA 6 awards $163.5M
- FL 4 awards $121.0M
- OH 4 awards $112.5M
- NY 3 awards $91.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who can apply for this grant?
Research institutions, universities, and clinical centers with capacity to conduct human subjects research. Device manufacturers and clinical investigators can partner through the Public Private Partnership program.
What types of devices are eligible?
Recording devices, stimulation devices, or combination systems for CNS applications. Both non-invasive (NSR) and invasive/implantable (SR/IDE) devices qualify.
Is this a rolling or fixed deadline?
This is a fixed deadline opportunity. Applications are not yet being solicited; notice provides time to develop collaborations before the formal NOFO releases.
What happens after funding?
Awards involve milestone-driven collaborative management with NIH program officers. Funded projects require joint responsibility for post-award oversight.
Do I need industry partnerships?
Partnerships with device manufacturers are encouraged but the Public Private Partnership is optional. Strong partnerships strengthen competitiveness.
💡 Tips for applicants
- Build your manufacturer partnership early. The PPP program explicitly aims to facilitate these collaborations and reduce negotiation barriers.
- Frame your study question clearly: explain why clinical data cannot be obtained through bench or animal studies alone due to device novelty.
- Address regulatory pathways upfront. Identify whether your device needs NSR or SR/IDE classification and outline your FDA strategy.
- Emphasize clinical significance. Connect your device's function to treating real CNS disorders and improving patient outcomes.
- Demonstrate institutional readiness. Show existing IRB infrastructure, clinical trial management experience, and safety protocols for human subjects work.
⚠️ Common mistakes
Weak or absent manufacturer partnerships—the program prioritizes reducing barriers to PPP collaborations. Unclear study design that doesn't justify why human clinical data is essential versus animal or bench testing. Insufficient attention to regulatory classification and FDA IDE requirements for invasive 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
- OPEN BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS (R18 – Clinical Trial Not Allowed) — National Institutes of Health
- OPEN BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (R61 Clinical Trial Not Allowed) — National Institutes of Health