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

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: May 29, 2024

Later deadlines: Sep 27, 2024, Jan 28, 2025, May 28, 2025, Sep 29, 2025, Jan 28, 2026, May 28, 2026, Sep 28, 2026, Jan 28, 2027

Grant amount: Up to US $7,500,000

Fields of work: Neurological Diseases & Disorders Medical Technology & Devices

Applicant type: Nonprofit, Government Entity, Indigenous Group, For-Profit Business

Funding uses: Research

Location of project: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Location of residency: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Overview:

NOTE: All applications are due by 5:00 PM local time of applicant organization. Optional but encouraged Letters of Intent are due 60 days prior to the full proposal deadline. 

The purpose of this Funding Opportunity Announcement (FOA) 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.

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US Dept. of Health & Human Services: National Institutes of Health (NIH)
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This page was last reviewed March 22, 2024 and last updated March 22, 2024