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BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)

US · MD · Bethesda National Institutes of Health (NIH) grant open #RFA-NS-25-022
Response due Sep 28, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications under the BRAIN Initiative to support clinical studies advancing next-generation neural devices capable of recording and modulating the human central nervous system. The opportunity uses the UH3 cooperative agreement mechanism and explicitly allows (but does not require) clinical trial components. The goal is to push the frontier of neurotechnology through human clinical research, building on prior preclinical or early-stage work. This is a federal grant opportunity posted on Grants.gov, not a traditional procurement contract.

What they want

Applicants must propose clinical studies focused on advancing next-generation devices for recording and/or modulation in the human central nervous system. Work is conducted under the UH3 cooperative agreement mechanism, which involves substantial NIH programmatic involvement. Clinical trials are optional but permitted. Research must align with the NIH BRAIN Initiative's goals to develop, test, and validate novel neurotechnology in human subjects.
Technical requirements
  • Proposed devices must be capable of recording and/or modulating activity in the human central nervous system
  • Clinical study design required
  • UH3 cooperative agreement mechanism applies
  • Clinical trial component is optional but must be declared if included
  • Must align with NIH BRAIN Initiative program goals

How they evaluate

Submission: Grants.gov electronic submission portal

Risks & flags

  • Extremely long open window (nearly 2 years) may indicate rolling review cycles rather than a single competitive round — applicants should confirm specific receipt/review dates in the full FOA
  • High technical specificity (next-generation CNS recording/modulation devices) may favor established neurotech research institutions with prior BRAIN Initiative funding

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

BRAIN Initiative: Clinical Studies to Adva…
Due Sep 28
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