Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
Last verified by NonDilute: 2026-06-08. Official notice and agency instructions control.
If you have a novel brain stimulation technology or breakthrough improvement to existing neuromodulation platforms, the NIH will fund hardware/software development (but not clinical testing) for mental health applications.
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What this is
This R21 mechanism supports development of brain stimulation devices that either introduce new stimulation modalities beyond traditional electrical/magnetic approaches or substantially enhance existing FDA-cleared devices through improved spatial resolution, depth, or closed-loop precision. Applicants must form multidisciplinary teams spanning systems neuroscience, engineering, clinical expertise, and regulatory affairs. Incremental improvements like software patches are out of scope; the focus is on meaningful innovation in spatiotemporal precision and multi-focal targeting.
Who can apply
Eligible applicants include small businesses, for-profit companies, nonprofits (501(c)(3) and non-501(c)(3)), universities, government agencies, tribal governments, and other institutional entities. Solo founders must operate as a registered small business or partner with an eligible organization. No geographic restrictions; U.S. federal funding mechanism.
Eligible applicant types
- Public housing authorities/Indian housing authorities
- For profit organizations other than small businesses
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Small businesses
- Special district governments
- Public and State controlled institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Private institutions of higher education
- County governments
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- State governments
- Independent school districts
- City or township governments
Full description — from the agency
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.
Topics: brain stimulation devices · neuromodulation · mental health treatment · closed-loop neurostimulation · FDA medical device · biomedical engineering
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.