13 November, 2012
Jerusalem, Israel - November 13, 2012 -- Further to that stated in the Brainsway® (TASE:BRIN) periodic report for 2011 regarding the 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 Company's Deep TMS device for the treatment of fatigue and depression symptoms in multiple sclerosis (MS) patients, the Company is pleased to announce the final results of the trial.
The final results are in respect of 28 patients (out of 34 recruited into the trial originally). The trial subjects were divided into three groups: a sham-stimulation control group, a treatment group that received high-frequency (18 Hz) left prefrontal stimulation, and an additional treatment group that received low-frequency (5 Hz) motor cortex stimulation. Each subject received a series of treatments, three times a week over six weeks. The effects of the treatment were evaluated during the treatment period and over the course of the subsequent 6-week period.
The effects of the treatment on subjects' fatigue levels were assessed using standard fatigue rating scales such as the Fatigue Severity Scale (FSS), the Modified Fatigue Impact Scale (MFIS), the Epworth Sleepiness Scale (ESS) and the Visual Analogue Scale (VAS); and its effects on subjects' depression levels were assessed using the Hamilton Rating Scale for Depression, the Beck Depression Inventory (BDI) and the Positive and Negative Affect Scale (PANAS). The present study was primarily concerned with treating fatigue and depression, and did not examine the stimulation parameters for treating the motor symptoms of MS.
Measures of Device Safety
No serious side effects were reported in the study. Mild side effects were reported by some of the subjects in each group, but these resolved on their own within a few days.
Efficacy of Deep TMS Device for Treatment of Depression and Fatigue Symptoms
Measures of Fatigue - Analysis of fatigue rating scale scores revealed a statistically significant (p<0.05) improvement on all scales in the 5-Hz motor cortex stimulation treatment group, with onset of improvement on some of the scales occurring only after the conclusion of the treatment series. In contrast, the 18-Hz left prefrontal stimulation treatment group exhibited significant improvement (p<0.05) in scores only on the ESS and VAS, while the sham-stimulation control group improved significantly (p<0.05) only on the VAS.
Measures of Depression - A significant improvement on the BDI and the PANAS was observed in the 5-Hz motor cortex stimulation group (p=0.001 and p=0.046, respectively), 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 fatigue and depression symptoms in MS patients. They also note that additional, more extensive studies should be performed to explore the effects of Deep TMS treatment.