The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics as well as surgical, behavioral or rehabilitation therapies. Only Phase II and Fast-Track applications are supported under this program. Phase I applications are only accepted as part of a Fast-track application.