FDA Approves BrainsGate Stroke Treatment Study
Published: Jul 27, 2012
BrainsGate Ltd. has obtained US Food and Drug Administration (FDA) approval for the clinical trial protocols for a study that the company began in June 2011 on its ischemic stroke treatment. The clinical trial includes 176 patients at 57 medical centers around the world. The FDA approval means that the company can recruit patients for the trial in the US. BrainsGate's technology uses electrical neurostimulation of the Spheno-Palatine Ganglion (SPG), a nervous center known to increase cerebral blood flow. It is designed to treat ischemic strokes with 24 hours of an event. Current pharmaceutical treatments, which include tPA proteins, are permitted only within 3-4.5 hours of a stroke.