Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional) | PAR 25 290

FAQs: NIH PAR-25-290 (R01) - Invasive Human Neural Recording for Mental Health-Relevant Questions

1) What is PAR-25-290 trying to fund?

PAR-25-290 is an NIH funding opportunity supporting R01 research projects that use invasive neural recording in humans to answer clearly defined scientific questions that are directly relevant to mental health. The emphasis is on leveraging implanted brain electrodes (typically implanted for clinical reasons) to measure neural activity with very high spatial and temporal precision, aiming to produce circuit-level explanations for mental health-relevant phenomena.

2) What kind of scientific questions fit this opportunity?

Projects should focus on mental health-relevant constructs and phenomena that benefit specifically from invasive, high-resolution measurements of human brain circuits. Examples mentioned include mood changes, emotional processing, cognition, and behavior, as well as clinically meaningful dimensions such as affect, cognitive control, threat processing, reward learning, and symptom-relevant behaviors.

3) Why does this NOFO emphasize invasive recording in humans?

The opportunity is motivated by a major gap in knowledge about how specific human neural circuits function and malfunction in mental health disorders. Invasive recordings can capture fast neural dynamics and localized circuit activity far better than noninvasive methods, which can enable more direct, circuit-level interpretations of complex mental health phenomena.

4) Does the NOFO allow or encourage stimulation as well as recording?

Yes. A distinctive feature is its emphasis on both recording and, when appropriate, stimulation using the same implanted electrodes. Stimulation is positioned as a way to move beyond correlation and test causality by perturbing a circuit and observing changes in network activity and mental health-relevant functions.

5) Is stimulation required for an application to be responsive?

The provided description frames stimulation as an emphasized and distinctive feature "when appropriate," rather than a universal requirement. The core requirement described is invasive neural recording in humans to address mental health-relevant scientific questions, with stimulation serving as an additional approach to test causality when it fits the project.

6) What is meant by "high translational potential" in this program?

Projects are expected to be positioned to inform how mental health disorders are understood in humans at the circuitry level and to generate knowledge that could realistically influence future diagnostics, biomarkers, or mechanistic frameworks. In other words, the work should produce clinically meaningful circuit knowledge, not just basic descriptive findings.

7) What is out of scope for PAR-25-290?

The opportunity draws a clear boundary around scope: developing brand-new technologies, devices, or therapies is not the goal. The focus is on using existing or clinically justified invasive recording and stimulation opportunities to generate fundamental, mechanistic insights about neural circuit function relevant to mental health disorders.

8) How does this NOFO differentiate from studies that could use EEG, fMRI, or behavioral testing?

Projects are expected to be tightly matched to what invasive methods are uniquely good at answering. The opportunity is not intended for studies that simply repeat questions that could be addressed adequately with noninvasive tools like EEG or fMRI, or with behavioral testing alone.

9) What grant mechanism is used for this opportunity?

This is an NIH discretionary grant opportunity using the R01 funding instrument.

10) Are clinical trials allowed under this announcement?

Yes. Clinical trials are optional under this announcement.

11) What is the CFDA number associated with this opportunity?

The listing identifies the program area as CFDA 93.242.

12) Who is eligible to apply?

The opportunity is open to a broad range of applicant organizations consistent with NIH eligibility standards. Eligible applicants include public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and multiple levels of government (state, county, city or township, and special districts), as well as independent school districts and public housing authorities/Indian housing authorities. It also includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments).

13) Does NIH explicitly encourage applications from specific types of institutions or communities?

Yes. The NOFO highlights "other eligible applicants" categories that signal an intent to encourage participation from diverse institutions and communities. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Indian/Native American Tribal Governments (other than federally recognized); eligible federal agencies; faith-based or community-based organizations; U.S. territories or possessions; regional organizations; and foreign (non-U.S.) organizations.

14) Are non-U.S. (foreign) organizations allowed to apply?

Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).

15) Does this NOFO expect studies to rely on already-implanted electrodes?

Yes. The main idea is to take advantage of situations where electrodes are already implanted in the human brain, for example in clinical contexts, and to use those existing or clinically justified invasive opportunities to record (and sometimes stimulate) in support of mental health-relevant mechanistic research.

16) What types of outcomes or deliverables is this program aiming for?

The stated aim is rigorous, clinically meaningful circuit knowledge: direct measurement-based links between neural circuit dynamics and mental health-relevant constructs or behaviors, potentially informing future diagnostics, biomarkers, or mechanistic frameworks. The program is not framed as a technology-development or therapy-development effort.

17) What is the application deadline (closing date) listed in the provided excerpt?

The provided listing states an original closing date of January 7, 2028.

18) When was this opportunity created?

The provided listing gives a creation date of November 22, 2024.

19) Is there an award ceiling or number of expected awards included in the excerpt?

No. The excerpt provided does not specify an award ceiling or the expected number of awards.

20) What is the overall purpose of the program in plain terms?

In plain terms, this is a targeted call for human neuroscience projects that can use rare but powerful invasive recording (and sometimes stimulation) opportunities to directly probe the neural circuitry underlying mental health disorders. The goal is to close key gaps in understanding human circuit function and dysfunction in ways that matter for mental health, without turning the program into a platform for building new devices or delivering new treatments.