JERUSALEM, Sept. 4, 2013 - Brainsway® Ltd. (TASE:BRIN) is pleased to report the final results of a clinical trial conducted at the Sheba Medical Center at Tel Hashomer to assess the efficacy of the Company's Deep TMS device in treating obsessive-compulsive disorder ("OCD") using a specialized coil developed for this purpose.
The double-blind, placebo-controlled study involved a total of 25 OCD patients that had previously failed to respond to both pharmacological and psychological therapy. The trial subjects were divided into three groups: a low-frequency treatment group, a high-frequency treatment group and a sham treatment group. The primary outcome measure for therapeutic efficacy was the change in patients' Yale-Brown Obsessive Compulsive Scale, or Y-BOCS, a standard test to rate the severity of OCD symptoms. In parallel, treated subjects underwent electroencephalography (EEG) measures in order to test objectively alterations in pathological neural activations that are associated with OCD.
The clinical results showed an average improvement of 27% in symptoms of patients in the high-frequency treatment group, which was significant relative to the sham-control treated group (p=0.0003). Average improvement in the low-frequency treatment group was 13% and did not reach statistical significance. In addition, EEG testing showed a reduction in pathological activity that correlated with treatment effect. In contrast, there were no patients in the sham treatment group that experienced improvement as measured clinically or by the EEG testing. Both real and sham treatments were well tolerated by patients and no side effects were reported in any of the treatment groups.
The principal investigator of the trial and a leading authority on OCD, Prof. Joseph Zohar, commented, "While these are preliminary data and would need to be confirmed, the results are very encouraging. Therefore, we recommend that a wide, international multi-center study be conducted to confirm these results."
Prof. Abraham Zangen, a co-investigator in this study and a scientific consultant for Brainsway, commented, "This is an important step forward and good news for OCD patients. We have considered several alternatives of the optimal brain target and related coil design, as well as stimulation parameters. This is the first study in which we show how EEG can be used to predict individual response to the treatment."