Grant opportunity · RFA-NS-25-022
BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
Who can apply (as listed)
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- Others (see the opportunity text)
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
- Native American tribal organizations (other than federally recognized governments)
- Native American tribal governments (federally recognized)
- County governments
- City or township governments
- Independent school districts
- Public housing authorities / Indian housing authorities
- Private institutions of higher education
- Public and state-controlled institutions of higher education
- Small businesses
- Special district governments
- For-profit organizations (other than small businesses)
- State governments
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 ani…
Excerpt as published. The full synopsis, required forms, and any amendments are on the official listing.
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