Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- PAR-25-286
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- County Governments
- Higher Education Inst. (Public)
- Other
- Small Businesses
- Tribal Organizations (Not Federally Recognized)
- Independent School Districts
- Tribal Governments (Federally Recognized)
- State Governments
- Special District Governments
- City/Township Governments
- Public or Indian Housing Auth.
- 501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- For Profit Organizations
- Non-501(c)(3) Nonprofits
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is soliciting applications for development of next-generation brain stimulation devices to treat mental health disorders, with an application deadline of January 7, 2028. This R21 mechanism does not allow clinical trials. Eligible applicants include nonprofits, small businesses, state and local governments, tribal organizations, academic institutions, and other entities listed in the NOFO; foreign organizations may apply. Applicants must develop either novel brain stimulation devices that move beyond existing electrical or magnetic stimulation techniques—incorporating increased spatiotemporal precision, multi-focal approaches, and closed-loop capability—or significantly enhance currently FDA-approved or cleared devices through hardware or software improvements that substantially increase spatial resolution, depth of delivery, or precision. Incremental changes such as software updates are not within scope. Applications must be submitted by multi-disciplinary teams with expertise spanning systems neuroscience, engineering, clinical affairs, and regulatory affairs. The program is funded under CFDA 93.242 (Mental Health Research Grants) administered by the National Institute of Mental Health. Cost share requirements, award ceiling, award floor, and expected number of awards are not specified in the NOFO materials provided. The project period structure and evaluation criteria follow standard NIH peer review processes, with applications evaluated on scientific and technical merit, program relevance, and program balance by an appropriate scientific review panel and the National Advisory Mental Health Council.
Synopsis
2 versions
Update #2 · Latest ·
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates)are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with a variety of expertise including systems neuroscience, engineering, clinical, and regulatory affairs.
Update #1 ·
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates)are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with diverse expertise including systems neuroscience, engineering, clinical, and regulatory affairs.
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-286-Full-Announcement.html | HTML file | |
| PKG00288886.pdf |
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