BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you have a novel neural recording or stimulation device and can run a small human feasibility study, this NIH program can fund the trial and connect you with pre-market device partners.
Report stale or inaccurate summary
What this is
This NIH program funds investigators running small clinical trials (either Non-Significant Risk or FDA Investigational Device Exemption studies) to test next-generation neuromodulation and recording devices in humans. The goal is to gather critical data on device function, safety, and design before advancing to larger trials or market approval. NIH has partnerships with device manufacturers (BRAIN PPP) to provide devices for research, potentially including pre-market technologies. Applicants should have a novel device concept and a clear clinical trial design answering specific questions about function or design that cannot be answered through bench or animal testing alone.
Who can apply
For-profit and non-profit organizations (including small businesses), universities, nonprofits, tribal organizations, and state/local governments are all eligible. Applicants must have institutional capacity to conduct human clinical research (IRB approval capability) and a specific device innovation ready for early human testing; solo founders without institutional affiliation will struggle.
Eligible applicant types
- Private institutions of higher education
- Native American tribal governments (Federally recognized)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- For profit organizations other than small businesses
- Independent school districts
- City or township governments
- Small businesses
- Native American tribal organizations (other than Federally recognized tribal governments)
- Public housing authorities/Indian housing authorities
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- State governments
- Public and State controlled institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Special district governments
- County governments
Full description — from the agency
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 market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm
Topics: brain-computer interface · neuromodulation device · clinical trial · neurotechnology · cns disorders · FDA IDE exemption · early feasibility study · BRAIN initiative
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.