Brainsway has announced positive final results from its double-blind, placebo-controlled study of its deep transcranial magnetic stimulation (Deep TMS) system for treating obsessive-compulsive disorder (OCD) using a specialised coil developed for this purpose.
The study conducted at the Sheba Medical Center at Tel Hashomer involved 25 OCD patients that had previously failed to respond to both pharmacological and psychological therapy.
Trial participants 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, an accepted scale for rating the severity of OCD symptoms.
In addition, all the treated subjects underwent electroencephalography (EEG) measures in order to test objectively alterations in pathological neural activations that are associated with OCD.
The data from the study 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).
In addition, 13% subjects in the low-frequency treatment group showed average improvement and did not reach statistical significance.
While EEG testing showed a reduction in pathological activity that correlated with treatment effect, no patients in the sham treatment group experienced improvement as measured clinically or by the EEG testing.
None of the treatment groups reported any side-effects and patients showed tolerance to both real and sham treatments.
The principal investigator of the trial and a leading authority on OCD, Prof Joseph Zohar said that although it was preliminary data and would need to be confirmed, the results were very encouraging.
"We recommend that a wide, international multi-centre study be conducted to confirm these results," Prof Zohar added.
Brainsway scientific consultant and co-investigator of the study Prof Abraham Zangen added that this was 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," Prof Zangen sai. "This is the first study in which we show how EEG can be used to predict individual response to the treatment."
The Deep TMS recently obtained a CE Mark approval for the treatment of autism, Alzheimer’s disease and smoking cessation.
According to GlobalData estimates, Deep brain stimulators market in the UK was valued at $16.4m in 2012 and is expected to grow at a CAGR of 11% to $34m by 2019.
Image: The Deep TMS system. Photo: courtesy of Brainsway Ltd.