Brainsway has reported the final results of a clinical trial conducted at the Sheba Medical Center in Tel Aviv, Israel, to assess the efficacy of the company's deep transcranial magnetic stimulation (Deep TMS) device in treating obsessive-compulsive disorder (OCD) using a specialised 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. 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' YaleâBrown Obsessive Compulsive Scale. In parallel, treated subjects underwent 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.
This is the first study in which the company shows that EEG can be used to predict individual response to the treatment. Brainsway has recommend that a wide, international multicentre study be conducted to confirm these results.
In January 2013, Brainsway's Deep TMS device was cleared by the FDA and Health Canada for the treatment of depression in patients who have failed to respond to antidepressant medications in their current episode of depression. The system was launched in the US for this indication in May.