Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional)

The National Institute of Mental Health (NIMH) invites applications for its R21 grant, designed to support exploratory research using invasive neural recording and stimulation in humans to deepen understanding of brain circuitry related to mental health disorders. This funding opportunity encourages innovative studies that utilize invasive neural recording techniques to gain high-resolution insights into brain dynamics that impact complex moods, cognition, and behaviors, which are key areas for mental health research. Researchers may leverage these neural recording methods to stimulate circuits and directly test causal relationships within brain networks. The ultimate goal is to advance foundational knowledge about the neural mechanisms underlying mental health disorders without the requirement for immediate therapeutic application, though tools that aid in future therapeutic study are welcome. A companion R01 funding opportunity is available for projects with extensive preliminary data. The R21 mechanism supports high-risk research with a two-year project period, encouraging projects that may lack preliminary data but show significant innovation potential. The maximum funding is $275,000 in direct costs across the two-year period, with no more than $200,000 in any one year. Projects should address mental health questions that have translational potential and should aim to yield insights that are specific to psychiatric and neuropsychiatric disorders. Eligible applicants include institutions of higher education, nonprofits, for-profit organizations, and certain local government entities, including international institutions and U.S. organizations with foreign components. Prior to application, institutions must have active registrations with SAM, NCAGE (for foreign applicants), eRA Commons, and Grants.gov. NIMH encourages diverse research teams, which may include experts from neurosurgery, electrophysiology, neuroscience, engineering, psychiatry, and psychology, to apply. Examples of qualifying research activities include intra-operative recordings, sub-acute recordings in an epilepsy monitoring unit, chronic recordings from DBS devices, and innovative use of technologies like AI/ML and virtual or augmented reality tools. Projects may employ mood and behavior assessments in clinical settings, linking these with neural recordings to explore how neural network activity varies with mental health-relevant states. While traditional therapeutic development studies and animal studies are outside this funding scope, clinical investigations using human patients and focusing on real-time brain dynamics are eligible. The application should focus on a clear research strategy detailing how the project will enhance the understanding of neural circuits relevant to mental health. Proposed projects should address the translational potential of their findings, describe the team’s capacity to conduct invasive research, and justify the relevance of behavioral and neural measures. Data management and sharing plans are mandatory, with all research data expected to be shared through the NIH National Data Archive (NDA) for broad research access. Applicants are responsible for developing an NDA submission plan, and funds should be allocated in the budget to meet these data-sharing requirements. Applications undergo NIH’s standard review process, focusing on criteria such as the project’s significance to the field, innovative aspects, research approach, feasibility, and environmental support for invasive research. Special attention will be given to the project’s potential for advancing neural circuit understanding and translational application. Proposals are reviewed for scientific merit, suitability of the research environment, and whether the budget is appropriate for the scope of the research. For applications involving clinical trials, reviewers will evaluate the study’s design, potential impact on clinical practice, and adequacy of participant recruitment and data management plans. Key dates include an earliest submission date of January 16, 2023, with subsequent due dates through January 8, 2025. Applicants are encouraged to submit their proposals well in advance of the due dates to allow for error correction and should consult the SF424 (R&R) Application Guide for detailed instructions. Following submission, applications are reviewed by NIH’s Center for Scientific Review and, if scored highly, will undergo advisory council review, with awards announced approximately six months post-review.