E-FIT phase III trial of NBT System following stroke supports benefits of therapy.- Nexstim.

Nexstim has completed its supplementary Phase III clinical trial, known as E-FIT (ELECTRIC FIELD NAVIGATED 1HZ RTMS FOR POST-STROKE MOTOR RECOVERY TRIAL), evaluating the use of Nexstim's NBT system in upper extremity motor rehabilitation following stroke. The supplemental E-FIT trial was conducted at five leading clinical centres in the US and recruited a planned total of 60 patients.

The E-FIT trial used a new sham comparator that was designed to provide data to supplement the completed Phase III NICHE trial, which demonstrated excellent results in the active group, with 2/3 patients showing a clinically meaningful response. In the primary efficacy analysis, the E-FIT trial dataset was combined with data from the active trial arm of the previously completed Phase III NICHE trial as recommended by the FDA. In the combined dataset no statistically significant difference in percentage of patients obtaining a clinically important improvement of hand and arm function between active and sham trial arms were observed.

Similarly, in a secondary analysis of the E-FIT dataset alone, no statistically significant differences between the trial arms were observed (60% vs 50%, active and sham NBT, respectively, p=0.62). The results in both trial arms exceeded the literature based response expectation of approximately 1/3 in occupational therapy alone.