Brainsway announced interim results for its double-blind clinical trial being conducted at the Charité Hospital in Berlin and at the University Medical Center Hamburg-Eppendorf in Hamburg to assess the safety and efficacy of the
Analysis of fatigue rating scale results revealed a significant improvement in FSS scores in the motor cortex stimulation treatment group, as well as a tendency towards significant improvement in the left prefrontal stimulation treatment group. A non-significant improvement in VAS scores was observed in the left prefrontal stimulation group, and both treatment groups also displayed non-significant improvement in MFIS scores. The control group showed either no improvement or only non-significant improvement on fatigue rating scales.
As for the treatment’s effect on depression, a significant improvement on the BDI and the PANAS was observed in the motor cortex stimulation group, while the other groups’ scores on these depression rating scales did not change significantly.
According to the investigators, these results indicate that Deep TMS therapy with the Company’s device is safe and effective for the treatment of MS patients, and that it may even alleviate these patients’ fatigue symptoms. They also note that the treatment’s effects on metabolic and neural activity have not yet been investigated, and will be addressed in future studies.