Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional) | PAR 21 289

Opportunity Information: Apply for PAR 21 289

The National Institutes of Health (NIH) funding opportunity titled "Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional)" (Funding Opportunity Number: PAR-21-289) supports research projects that use invasive neural recordings in humans to answer questions that are directly relevant to mental health. This announcement is a reissue of an earlier solicitation (RFA-20-350) and is intended to push forward what is known about how human brain circuits generate and regulate mood, emotion, cognition, and behavior, especially where those functions are disrupted in psychiatric and related mental health disorders. It uses the R01 grant mechanism, and clinical trials are optional, meaning applicants can propose either clinical trial or non-clinical trial human research as long as it fits the goals of the program.

The core idea behind the FOA is that invasive recordings offer a rare and unusually detailed view into human brain activity. Compared to noninvasive methods, implanted or intraoperative electrodes can capture neural signals with very high temporal precision and strong spatial specificity, allowing researchers to observe fast-changing neural dynamics and circuit-level interactions as they happen. The FOA emphasizes studies that take advantage of this level of access to investigate neural circuitry underlying complex psychological phenomena such as affective states, emotional processing, decision-making, cognitive control, learning, and behavior. The program is designed to fill a specific gap in scientific knowledge: despite major progress in neuroscience, there remains limited direct evidence in humans about the circuit mechanisms that relate to mental health conditions, and invasive recordings are one of the few ways to bridge that gap.

A distinctive feature highlighted in the announcement is the combined ability to both record from and stimulate the brain using the same implanted electrodes. Stimulation can be used to probe causality rather than correlation, for example by perturbing a circuit and measuring how network activity and behavior change. In that sense, the FOA encourages study designs that move beyond simply observing neural activity to also testing mechanistic hypotheses about how circuit dynamics contribute to symptoms, traits, or clinically meaningful behaviors. The emphasis is on well-justified scientific questions that are particularly well suited to invasive human recording and stimulation, and that have clear translational potential for understanding mental health disorders at the circuit level.

At the same time, the FOA draws a boundary around what it will and will not support. While it is interested in studies that could ultimately inform future clinical advances, it explicitly states that developing new technologies and developing new therapies are outside the scope of this announcement. In practice, that means proposals should not be framed primarily as device development, engineering optimization, or therapy creation. Instead, the work should be centered on basic and translational neuroscience questions about circuit function and dysfunction in humans, using invasive recording and, when appropriate, stimulation as the key tools.

The opportunity is categorized as discretionary grant funding in the health area and is associated with CFDA number 93.242. A wide range of organizations are eligible to apply. Beyond the typical applicants such as public and private institutions of higher education, nonprofit organizations (including those with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, eligibility also includes various government entities (state, county, city or township, special districts, independent school districts, and eligible federal agencies), public housing authorities/Indian housing authorities, and Native American tribal governments and organizations (including both federally recognized tribal governments and other tribal organizations). The FOA also explicitly calls out additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations).

Key administrative details provided in the source include an original closing date of January 6, 2023, and a creation date of July 28, 2021. The award ceiling and expected number of awards are not specified in the provided listing. Overall, the announcement targets investigators who can leverage rare clinical or research opportunities for invasive access to the human brain, and who can translate that access into rigorous, hypothesis-driven studies that clarify how neural circuits and neural dynamics relate to mental health disorders.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2021-07-28.
• Applicants must submit their applications by 2023-01-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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