Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery

To assess the safety and preliminary efficacy of combining intravenous rt-PA with transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within 3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute ischemic stroke. The wavelength of the laser light is in the infrared zone of the electromagnetic spectrum and is invisible to the naked eye.