Medical devices developer Brainsway has reported positive final results from a double-blind, placebo-controlled study, designed to assess the therapeutic efficacy of its Deep TMS device in treating obsessive-compulsive disorder (OCD) using a specialized coil.
The trial subjects were divided into a low-frequency treatment group, a high-frequency treatment group and a sham treatment group.
The primary endpoint measure for therapeutic efficacy of Deep TMS device was the change in patients’ Yale–Brown Obsessive Compulsive Scale, or Y-BOCS, a standard test to rate the severity of OCD symptoms.
In addition, 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, while none of the patients in the sham treatment group experienced improvement as measured clinically or by the EEG testing. In the low-frequency treatment group, the average improvement was 13%.
In addition, EEG testing showed a fall in pathological activity that correlated with treatment effect.
However, no side effects were reported in all the three treatment groups.
The study, which was conducted at the Sheba Medical Center in Tel Hashomer, enrolled 25 patients with OCD who earlier failed to respond to both pharmacological and psychological therapy.