BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
About
The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e. g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e. g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet mar.
The BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) is a federal funding opportunity designed to support researchers and innovators developing cutting-edge neural recording and stimulation devices. This grant program encourages investigators to conduct small-scale clinical trials that generate critical data needed to advance brain-computer interface technologies and neuromodulation devices for treating central nervous system disorders. The program supports both acute/short-term procedures classified as Non-Significant Risk (NSR) and longer-term Significant Risk (SR) studies requiring FDA Investigational Device Exemption (IDE) approval, including chronic implants. Entrepreneurs and research institutions should apply if they have novel neurotechnology devices that require human clinical validation but cannot obtain necessary data through bench-top or animal studies alone. The NIH BRAIN Public-Private Partnership Program provides access to devices from manufacturers, accelerating the path toward market approval. This is an excellent opportunity for academic medical centers, biotech companies, device manufacturers, and eligible institutions to bridge the gap between preclinical development and advanced clinical trials while contributing to breakthrough discoveries in brain science and neuromodulation therapies.
Funding Facts
● Applications openDeadline
September 28, 2026
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by application cycle
Deadline
2026-09-28
Grant Type
federal
Application Cycle
Annual (Next deadline: September 28, 2026)
Best For
Neurotechnology researchers, device manufacturers, academic medical centers, biotech companies, and eligible institutions developing brain-computer interfaces and neuromodulation devices
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 Govern
Frequently Asked Questions
Who is eligible for BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)?
Eligible applicants include academic research institutions, HBCUs (Historically Black Colleges and Universities), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs (Asian American Native American Pacific Islander Serving Institutions), eligible federal agencies, faith-based and community-based organizations, and other research entities. For complete and current eligibility requirements, please visit the official NIH BRAIN Initiative funding announcement page.
How much funding does BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) provide?
Specific funding amounts are not listed in the current program announcement. Award amounts vary based on the scope and complexity of the proposed clinical trial. Visit the official NIH BRAIN Initiative website or the specific funding opportunity announcement for current funding details and budget limitations.
How do I apply for BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)?
Applications are typically submitted through NIH's Grants.gov portal using the required application forms and guidelines. Your application should include a detailed protocol for the proposed clinical trial, device specifications, IRB/FDA documentation plans, and data collection strategies. The next deadline is September 28, 2026. Consult the official NIH BRAIN Initiative website for detailed application instructions, required forms, and submission procedures.
What can BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) funding be used for?
Funding supports small clinical trials designed to advance neural recording and modulation devices for treating CNS disorders. Allowable activities include conducting feasibility studies, collecting critical device function and design data, performing acute or short-term clinical procedures, supporting chronic implant studies, and generating information that cannot be obtained through non-clinical testing. The program emphasizes advancing devices toward FDA approval and market deployment through rigorous human clinical validation.
Last updated: July 5, 2026