This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera Laser System (referred to hereafter as NTS) in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset. The NeuroThera Laser System is an investigational device that provides non-invasive transcranial laser treatment to subjects diagnosed with acute ischemic stroke. This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 subjects at up to 50 investigational sites (United States of America and international centers combined). The study population will be randomized into two arms: Sham Control Group (SCG) and Experimental Treatment Group (ETG). In general, patients eligible for study participation will be diagnosed with acute ischemic stroke and present to the Health Care Facility at a time such that NTS treatment will be feasible within 24 hours of the time of stroke onset. In addition, subjects will need to be between 40 and 90 years of age on the date of screening. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria. It is expected that the subjects will participate in the study for 90 days. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating, (hereafter referred to as the 90-day result). The safety endpoints include the cumulative investigational device-related adverse event-free survival through 90 days of follow-up, the cumulative procedure-related adverse event-free survival through 90 days of follow-up, the number and percent of cumulative unanticipated investigational device-related, and cumulative unanticipated procedure-related adverse events through 90 days of follow-up after treatment with the NTS, and the safety of NTS in the delivery of infrared energy to the intended site based on adverse events though 90 days.
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