Clinical Data

BrainsGate evaluated the safety and efficacy of SPG stimulation for the treatment of acute ischemic stroke in four clinical trials:

ImpACT-1 - a 98 patients feasibility, open label study with main findings being the SPG stimulation is both feasible and tolerable. The study results were published by Plos One

ImpACT-24A - a 253 patients randomized, sham-controlled, double-masked trial at 41 centers in 7 countries, patients with anterior circulation ischemic stroke within 24 hours of onset. Study showed SPG stimulation is safe and provided a signal of efficacy. Study results were published by Stroke

ImpACT-24B - a 1,000 patients randomised, double-blind, sham-controlled, pivotal trial done at 73 centres in 18 countries. The pivotal ImpACT-24B trial aimed to determine whether sphenopalatine ganglion stimulation 8–24 h after acute ischaemic stroke improved functional outcome. Study results were published by The Lancet

ImpACT-24M - a 50 patients single arm usability study aimed to demonstrate the usability aspects of the ISS500 device. Study showed that setting the correct stimulation level for each patient is simple, and that the implantation procedure of the Implantable Nuero Stimulator (INS) takes less than 5 minutes skin to skin time. Study results were published by Stroke