BRAIN Initiative Research Grants

Clinical Studies to Advance Next-Generation Devices for Recording/Modulation in Human CNS

Funds human clinical studies of next-generation neural devices through research agreements.

RFA-NS-25-022, issued under the NIH BRAIN Initiative with NINDS as lead Institute, funds UH3 cooperative agreement grants for clinical studies advancing next-generation devices for recording and modulating neural activity in the human central nervous system. This NOFO represents the clinical-translation phase of the BRAIN Initiative's neural device development track; applicants at this stage are expected to have already completed device development milestones comparable to those required in the precursor UG3 phase funded under RFA-NS-25-021. As a cooperative agreement, NIH plays an active role in directing and overseeing project activities throughout the award period.

Eligible applicants are U.S. universities and non-profit research organizations registered and operating within the United States. For-profit entities and individual investigators may not apply as primary recipients. Award amounts are not specified in the public structured record, but UH3 clinical-studies grants typically carry substantial multi-year budgets to cover device procurement, regulatory preparation, and human subjects research costs.

Applicants competing for this award should demonstrate that their device has cleared the engineering-validation stage and is ready for rigorous clinical evaluation in human participants. Review panels will examine the quality of the investigational device exemption or equivalent regulatory strategy, the clinical team's track record in first-in-human studies, and the scientific rigor of outcome measures. Institutions with existing relationships to relevant clinical populations and established regulatory affairs infrastructure are best positioned to succeed.