Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional)

The National Institutes of Health (NIH), particularly the National Institute of Mental Health (NIMH), has announced a funding opportunity for researchers to study neural circuits in mental health disorders using invasive recording and stimulation techniques in human subjects. This funding opportunity, under the R01 Research Project Grant mechanism, supports long-term projects that leverage invasive neural recording methods to examine the brain activity underlying complex mental functions such as mood, cognition, and behavior. Through recording and stimulating neural circuits, researchers can investigate brain dynamics with high spatial and temporal precision, aiming to clarify brain network interactions that correlate with mental health symptoms. Although this research may indirectly inform therapeutic methods, developing treatments is not within the scope of this funding. Rather, it encourages novel approaches and tool development for studying the brain's role in mental health, with emphasis on studies that bear significant translational potential. The program targets research that can exploit various invasive recording opportunities, including intraoperative micro-electrode recordings, electrocorticography (ECoG) during epilepsy monitoring, and deep brain stimulation (DBS) devices capable of both recording and stimulation. Such approaches may involve monitoring patient mood and behavior in relation to recorded neural activity, allowing researchers to causally test and manipulate brain circuits to understand mental health disorders. Interventions such as direct brain stimulation are permitted, provided they are designed to test hypotheses about neural circuitry rather than to develop a treatment per se. The initiative encourages interdisciplinary teams, including professionals from neurosurgery, electrophysiology, engineering, and psychiatry, who can utilize this invasive recording capability within a clinically feasible setting. Funding for this program is unrestricted but must be justified according to project needs, with a maximum project duration of five years. Eligible applicants include U.S. and foreign higher education institutions, nonprofit organizations, for-profit entities, government agencies, and certain other institutions. NIMH particularly encourages proposals from institutions serving historically marginalized groups. Required institutional registrations include System for Award Management (SAM), NATO CAGE code for foreign applicants, and NIH eRA Commons, among others. Proposals may be submitted through NIH's ASSIST, institutional S2S, or Grants.gov systems. Applications should be structured to highlight how the research addresses specific neural circuits related to mental health and includes novel approaches in methodology, such as using digital health tools for behavioral tracking. Page limits and application structure should follow NIH’s SF424 (R&R) guidelines, and a letter of intent is recommended but not mandatory. Applications that do not adhere to the instructions or omit required elements risk delays or rejection. The program’s data-sharing plan mandates that grantees share data through the NIH National Data Archive (NDA), ensuring accessibility and interoperability across studies. The review process will assess applications based on significance, innovation, and approach. Reviewers will consider the translational potential, methodological rigor, and suitability of the research environment. A diverse and interdisciplinary research team, a robust data-sharing plan, and a strong ethical approach to human subject protections will also factor into the evaluation. Following the scientific peer review, applications undergo a second level of review by the National Advisory Mental Health Council, with final funding decisions based on scientific merit, funding availability, and relevance to NIMH’s priorities. Key deadlines include rolling submission dates starting from January 2023, with applications due three times a year on February 5, June 5, and October 5. Applicants are encouraged to apply early to allow for submission corrections and to address any system issues that may arise. The current expiration date for this FOA is January 8, 2025.