BrainsGate has obtained FDA approval for the clinical trial protocols for a study that the company began in June 2011 on its ischaemic stroke treatment. The clinical trial includes 176 patients at 57 medical centres around the world. The FDA approval means that the company can recruit patients for the trial in the USA.
BrainsGate’s technology uses electrical neurostimulation of the Spheno-Palatine Ganglion (SPG), a nervous centre known to increase cerebral blood flow. It is designed to treat ischaemic 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.
The World Health Organization estimates the direct cost of ischaemic strokes at US$73.7 billion, and that 15 million worldwide suffer strokes every year. Ischaemic stroke is a leading cause of long-term disability. Due to the short treatment window of current treatments, only 5% of victims receive medical treatment, a proportion that could increase thanks to the longer treatment window that BrainsGate’s technology offers.
BrainsGate expects to complete the trial on 450 patients in the fourth quarter of 2013.