The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) under the BRAIN Initiative, titled Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System. This program supports early-stage clinical investigations of innovative neural devices to treat central nervous system (CNS) disorders and advance our understanding of the human brain. The initiative targets devices requiring FDA Investigational Device Exemption (IDE) due to their significant risk. Projects should answer critical design and functional questions that cannot be addressed through preclinical studies and are milestone-driven with NIH program staff oversight.

This NOFO expects to fund 5–7 awards annually, with total funding of $10 million per year. Budgets are not capped but should not typically exceed $1.5 million in direct costs annually. Projects may span up to five years, with allowable activities including first-in-human trials, feasibility studies, and validation of device designs. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and state or local governments, though foreign organizations are excluded. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) and address health equity, ethical considerations, and regulatory compliance.

Applicants should align their proposals with the BRAIN Initiative’s goals, leveraging existing collaborations or engaging with the Public-Private Partnership Program (PPP). These partnerships enable access to cutting-edge devices and pre-existing safety data, facilitating FDA and Institutional Review Board (IRB) approvals. Proposals may also include novel device designs aimed at addressing CNS disorders, ensuring synchronization with ambulatory and behavioral data for real-time analysis. The initiative encourages inclusivity by fostering diverse research teams and enhancing representation in clinical research.

Key submission requirements include a detailed project narrative, Gantt chart, long-term patient care plan, milestones with success criteria, and data management and sharing plans. A Needs Assessment must outline the project’s relevance to unmet clinical needs, supported by stakeholder feedback. Intellectual property strategies and team management plans are also mandatory. Applicants must register with SAM.gov and eRA Commons before submitting proposals through NIH ASSIST or Grants.gov.

Applications are due January 28, 2025, and September 28, 2026, with mandatory Letters of Intent due 60 days prior. The review process emphasizes scientific merit, feasibility, and impact, along with NIH's commitment to equitable research practices. Progress is assessed against pre-negotiated milestones, with funding continuation contingent on meeting benchmarks. The awards require adherence to NIH guidelines for data sharing and human subjects protection.

This NOFO reflects the BRAIN Initiative’s broader goals of advancing neuroscience technologies and fostering collaboration across sectors. Applicants are encouraged to consult NIH staff before submission for guidance on aligning their proposals with program objectives and meeting regulatory requirements. Additional resources and templates are available on the BRAIN Initiative's website.