BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) - RFA-NS-25-022
Funder
National Institutes of Health
LOI Deadline
LOI Required
Recommended, but not required
Application Deadline
Maximum Project Duration
5 years
Research Focus Areas
Brain Stimulation Therapies/Neuromodulation (TMS, VNS, DBS, ECT)
Neurobiology/Neuroscience
Molecular and Cellular
Research Methods
Magnetic Resonance Imaging (MRI)/Other Imaging
Randomized Control Trials (RCT)
Description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue first-in-human or early stage clinical studies for recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Only Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants, will be supported by this NOFO. The clinical study is expected to provide data to answer key questions about the function or final design of a device and 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 NOFO is part of 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.