BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)

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.

Source officielle

Beneficiarios elegibles

• Public housing authorities/Indian housing authorities
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• City or township governments
• Special district governments
• Native American tribal governments (Federally recognized)
• State 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
• County governments
• Native American tribal organizations (other than Federally recognized tribal governments)
• Private institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• For profit organizations other than small businesses
• Small businesses
• Independent school districts