BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
National Institutes of Health
Award ceiling
—Award floor
—Posted
Nov 5, 2024Closes
Sep 28, 2026Location eligibility
No specific state restriction found in this listing — check the full opportunity for details.Categories: Education, Health, Income Security and Social Services
Eligible applicants: For profit organizations other than small businesses, 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, Native American tribal governments (Federally recognized), Independent school districts, Special district governments, Native American tribal organizations (other than Federally recognized tribal governments), State governments, Small businesses, Others (see text field entitled "Additional Information on Eligibility" for clarification), City or township governments, County governments, Public and State controlled institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education
Description
The purpose of this announcement is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design 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. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.