In July 2006, BrainsGate initiated ImPACT-1: a pilot clinical study to assess the safety and efficacy of SPG stimulation for treatment of acute ischemic stroke in a 24 hour window from stroke onset. ImPACT-1 completed its recruitment in late 2008, haveing enrolled 98 patients. Results from ImPACT-1 were published in several conferences during 2008 (see publications).
Following the promising results of ImpACT-1, BriansGate has launched ImpACT-24: a randomized, double-blind, sham-controlled study to assess the safety and efficacy of SPG stimulation in a 24 hour window from symptom onset. ImpACT-24 is a multi-national trial with centers in America, Europe and Asia, and is currently enrolling patients. The study was concluded in 2011 providing strong support to the ImpACT-1 outcomes, leading the way to the ImpACT-24B pivotal trial that is currently enrolling patients.
For more information about ImpACT-24 or if you want to join the study please contact us.