Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Optional) | PAR 18 942

FAQs: NIH PAR 18-942 (R01) Neuromodulation and Neurostimulation Device Development for Mental Health

What is this funding opportunity?

This is a National Institutes of Health (NIH) discretionary grant funding opportunity (FOA: PAR 18-942) that supports R01 grant applications to develop the next generation of neuromodulation and neurostimulation devices intended to treat mental health disorders.

What is the main goal of PAR 18-942?

The central goal is device development that meaningfully advances how brain stimulation can be delivered for psychiatric indications, either by creating entirely new stimulation technologies or by making major, capability-changing improvements to devices that are already FDA-approved or FDA-cleared.

What grant mechanism does this FOA use?

This opportunity uses the NIH R01 mechanism, which typically supports substantial, multi-year research and development programs that are well-scoped and appropriate for a significant effort.

What kinds of projects are encouraged under this FOA?

The FOA highlights two broad categories of projects: (1) truly novel brain stimulation devices that move beyond conventional electrical or magnetic stimulation approaches, and (2) major hardware and/or software improvements to existing FDA-approved or FDA-cleared brain stimulation devices, as long as the improvements represent a major functional upgrade rather than incremental refinement.

Does the FOA allow clinical trials?

Yes. A clinical trial is allowed under this announcement, but it is optional. Projects may range from advanced engineering and preclinical development through human testing when justified.

Are only human studies supported, or can preclinical work be proposed?

Preclinical and engineering-focused work is within scope. The FOA states that projects may range from advanced engineering and preclinical development through human testing when justified.

What does the FOA mean by "truly novel" brain stimulation devices?

In this FOA, "truly novel" refers to device concepts that move beyond conventional electrical or magnetic stimulation approaches and are expected to provide substantial gains in spatiotemporal precision, including improved ability to target the right brain areas with better accuracy in both space and timing.

What technical capabilities are emphasized for novel devices?

The FOA explicitly emphasizes substantial gains in spatiotemporal precision and encourages multi-focal stimulation (stimulating multiple targets) and closed-loop systems that adapt stimulation based on real-time signals.

What is meant by "spatiotemporal precision" in this FOA?

Spatiotemporal precision refers to improving both where stimulation is delivered in the brain (spatial targeting accuracy/selectivity) and when/how it is delivered over time (timing control), with the goal of engaging relevant circuits more precisely for psychiatric indications.

What does "multi-focal" stimulation mean in this context?

Multi-focal approaches are those that can stimulate multiple targets rather than a single site, which may be important for engaging distributed brain circuits relevant to mental health disorders.

What is a "closed-loop" neuromodulation system as described in the FOA?

Closed-loop systems are device approaches that can sense relevant neural or physiological activity, interpret it quickly, and automatically adjust stimulation parameters in real time to optimize therapeutic effects and reduce side effects.

Can projects propose improvements to existing FDA-approved or FDA-cleared devices?

Yes, but only if the proposed hardware and/or software changes represent a major functional upgrade that significantly enhances effectiveness, rather than a minor refinement.

What kinds of upgrades to existing devices are considered competitive?

Competitive upgrades would generally be expected to add new clinically meaningful capabilities, such as substantially better spatial resolution (more selective targeting), greater depth of delivery (reaching deeper neural structures noninvasively or more effectively), and/or higher overall precision and control over stimulation delivery.

Are incremental improvements to existing devices allowed?

No. The FOA states that incremental updates are out of scope. Examples of changes that would not be responsive include routine software updates or modest feature tweaks that do not fundamentally change performance.

What therapeutic area is targeted by this FOA?

The FOA is aimed at developing brain stimulation tools for treating mental health disorders, with an emphasis on psychiatric indications.

Is this opportunity limited to conventional electrical or magnetic stimulation?

No. One of the two main project categories specifically invites novel device concepts that move beyond conventional electrical or magnetic stimulation approaches.

What is the CFDA number and activity category listed for this opportunity?

The opportunity is listed under the health activity category with CFDA 93.242.

Who is eligible to apply?

Eligibility is broad and includes a wide range of organizations, such as government entities (state, county, city/township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, non-federally recognized tribal organizations, public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated), for-profit organizations other than small businesses, and small businesses.

Are specific types of institutions explicitly called out as eligible?

Yes. The FOA also calls out Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can non-U.S. (foreign) organizations apply?

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

Is the award amount (ceiling) stated in the provided opportunity summary?

No. The provided source text does not specify an award ceiling.

Does the provided summary state how many awards NIH expects to make?

No. The provided source text does not specify the expected number of awards.

What was the original closing date listed for this posting?

The original closing date listed for this particular posting was September 7, 2021.

What does NIH appear to prioritize overall in this FOA?

The FOA prioritizes meaningful technological leaps in neuromodulation and neurostimulation for mental health treatment, especially advances that improve targeting, depth, precision, and adaptability (including closed-loop control), rather than small incremental revisions to existing devices.