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This document is a Request for Application (RFA) for the BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional). The purpose of this announcement is to encourage investigators to pursue small clinical trials to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Eligible applicant types include higher education institutions, small businesses, non-profit organizations, and state/local governments. The funding opportunity is supported by several NIH institutes and centers, including the National Institute of Mental Health, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Biomedical Imaging and Bioengineering, National Institute of Neurological Disorders and Stroke, National Institute on Aging, and National Center for Complementary and Integrative Health. The clinical trials are expected to provide information that cannot be obtained through additional non-clinical assessments and may consist of acute, short-term procedures or chronic implants requiring an Investigational Device Exemption.

RFA-NS-25-022 Full Announcement Text

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