Notice of Intent to Publish a Funding Opportunity Announcement for Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Optional)

Notice Number: NOT-MH-18-037

Key Dates

Release Date:July 23, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 05, 2018
First Estimated Application Due Date: February 05, 2019
Earliest Estimated Award Date: September 05, 2019
Earliest Estimated Start Date: December 05, 2019

Related Announcements

Issued by
National Institute of Mental Health (NIMH)


The NIMH intends to publish a new Funding Opportunity Announcement (FOA) to support the next generation of brain stimulation devices for treating mental health disorders through the R01 activity code.

This Notice is being provided to allow potential applicants with expertise and insights into the area of brain stimulation devices and related technologies sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Fall 2018 with an expected application due date in Winter 2018.

Research Initiative Details
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. Applications should be submitted by multi-disciplinary teams with diverse expertise including systems neuroscience, engineering, clinical, and regulatory affairs. Applications submitted in response to this FOA should promote either the development of novel tools (hardware/software) or significant enhancement of existing tools (hardware/software); however, animal and other benchtop studies required to develop and validate the tool in preparation for regulatory approval for clinical studies are appropriate. Applications to this FOA are not expected to be hypothesis-driven, but should propose design-directed, developmental, or discovery-driven technology research using integrative approaches. Applications that seek to study scientific or clinical hypotheses that solely utilize devices are outside the scope of this FOA.

Funding Information

Estimated Total Funding
Expected Number of Awards
Estimated Award Ceiling
Primary CFDA Numbers 93.242

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time.


Please direct all inquiries to:

David McMullen, M.D.
National Institute of Mental Health (NIMH)