The trial demonstrated a statistically significant reduction in seizure frequency in the treatment group (responsive stimulation active) as compared to the sham stimulation group (responsive stimulation inactive). During the last two months of the three month blinded evaluation period of the study, people in the treatment group experienced a mean percentage reduction of 29 percent in their disabling seizures compared to 14 percent reduction for those in the sham stimulation group. In the long term, open label period of the trial, at least 12 weeks of data were available for 171 study participants; 47 percent of these subjects experienced a 50 percent or greater reduction in their seizure frequency based on their most recent 12 weeks of data, as compared to their baseline.
The trial also demonstrated a serious adverse event rate less than comparative surgical procedures. There were no serious unanticipated device related adverse events reported in the trial. There was no difference between the treatment and sham stimulation groups when comparing the rate of adverse events, including depression, memory impairment and anxiety.
Source: Porter Novelli, Life Sciences