BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System
Funding Organization: National Institutes of Health (NIH)
Total funding amount: $10 million per year
Duration: Up to 5 years (1 year for UG3 phase and 1-4 years for UH3 phase)
To encourage translational activities and small clinical studies for devices treating central nervous system disorders.
Support regulatory activities necessary for clinical studies.
Investigators and researchers in neuroscience.
Patients with central nervous system disorders.
Device manufacturers and academic institutions.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local and state governments, and tribal governments.
Non-domestic entities (foreign organizations) are not eligible to apply.
Eligible applicants must be based in the United States.
Non-domestic components of U.S. organizations are not eligible.
Projects must focus on devices for central nervous system disorders.
Must include regulatory activities and clinical studies requiring an Investigational Device Exemption (IDE).
Direct costs for UG3 phase should not exceed $500,000 per year.
Direct costs for UH3 phase should rarely exceed $1,500,000 per year.
Application deadlines: New applications due by September 28, 2026.
UG3 phase must last 1 year; UH3 phase can last 1-4 years.
Applicants may submit more than one application if each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications.
Applications must include a Gantt chart, Needs Assessment, Intellectual Property Strategy, and Long-term Care Plan for Patients.
Applications will be evaluated based on significance, innovation, approach, and investigator expertise.
Applications will undergo peer review and receive a written critique.
Funding decisions will be based on scientific merit and availability of funds.
Applications addressing critical gaps in knowledge and demonstrating innovative approaches will be prioritized.
The program involves substantial NIH staff participation in project planning and monitoring.
Non-domestic entities are excluded from applying.
Encourages partnerships between clinical investigators and device manufacturers.
Strong emphasis on milestone-driven projects may favor well-prepared applicants.
Clear and achievable milestones.
Strong regulatory strategy and engagement with the FDA.
Submitting incomplete applications or failing to meet regulatory requirements.
Engage with NIH program staff early in the application process.
Highlight innovative aspects of the proposed device and its potential impact on clinical practice.