Brainsway® Announces Positive Final Results
of its Deep-TMS Multicenter Study in Obsessive Compulsive Disorder (OCD) Patients
Patients who received active treatment were significantly better than those who received sham treatment.
Brainsway will prepare a submission to the FDA to market the device for OCD.
Jerusalem, Israel – June 12, 2017 Brainsway Ltd. (TASE: BRIN), the parent company of Brainsway USA, Inc. and a global leader in the advanced non-invasive treatment of brain disorders, announced today the final results of a double-blind placebo controlled (DBPC) multicenter study conducted on its device in patients suffering from Obsessive Compulsive Disorder (OCD).
The multicenter study in OCD was conducted in a total of eleven medical centers, with nine located in the United States, one in Canada and one in Israel. Ninety-four patients who previously failed to sufficiently respond to pharmacological or psychological treatment were enrolled in the trial. The treatment protocol consisted of thirty-minute sessions conducted five times per week, over a course of six weeks with the Brainsway H7-deep-TMS system.
The primary outcome measure was the OCD Yale–Brown Obsessive Compulsive Scale (Y-BOCS), the gold standard measure of OCD symptoms severity. The results showed that after 6 weeks of treatment, there was a statistically significant improvement in the YBOCS score for the active treatment group when compared to sham (p=0.0157). Importantly, 38.1% of patients in the active group achieved a response as defined in the protocol, compared with just 11.1% in the sham group (p=0.0033). Furthermore, 54.8% of patients in the active group achieved a partial response as defined in the protocol, versus just 26.7% in the sham group (p=0.0076). The improved clinical effect in YBOCS scores was maintained in the active group one month after treatment completion, and the improvement was more pronounced than that achieved in the sham group (p=0.0459).
Based on the results of the study, the company will prepare a submission to the FDA in order to enable Brainsway to market the device for the indication tested.
Yaacov Michlin, CEO of Brainsway, states: “Today’s announcement demonstrates that Deep TMS is a wide platform with potentially far-reaching implications for the treatment of numerous brain disorders. Being the first study of its kind, it distinguishes Brainsway's Deep-TMS system and stimulation approach from other technologies and represents a meaningful milestone in innovation for OCD.”
“The H7 coil we developed for the stimulation of the anterior cingulate cortex region in the brain has now demonstrated significant potential in a large multicenter study conducted by key opinion leaders at world-leading institutions,” said Prof. Abraham Zangen, one of the inventors of the Deep TMS technology and a Co-PI of the study.
Professor Joseph Zohar, a worldwide expert in OCD and a Co-PI of the trial, states: “Brainsway's approach is to directly modulate the neural network in the brain associated with OCD. We have the exciting potential for a completely new, non-pharmacological and non-psychological tool in the battle against OCD. The study reveals that applying focused magnetic stimulation may bring promising clinical outcomes for what has long been considered a hard-to-treat disease."
According to Aron Tendler MD, Chief Medical Officer of Brainsway: “About one percent of the U.S. population are diagnosed with OCD each year and over half will not respond to other treatment alternatives. Since only moderate and severe OCD patients who failed to respond to prior treatment were recruited, this groundbreaking study should be particularly encouraging for these patients and their caregivers.”
Obsessive-compulsive disorder (OCD) is a severe chronic psychiatric disease, characterized by a pattern of obsessive thoughts and compulsive repetitive behaviors, which has a significantly destructive effect on patients’ day-to-day functioning. The accepted treatment is SSRIs antidepressant medications (that are given at very high doses for OCD patients), or cognitive-behavioral treatment (CBT), or a combination thereof. The OCD disease is very difficult to treat since many patients do not respond to pharmacologic or CBT treatment, and many have difficulty tolerating the side effects of the pharmacological treatment.