Brainsway, Israel’s leading magnetic stimulation company, won FDA de novo clearance for its system to be used to treat obsessive compulsive disorder (OCD) in the United States. The company’s Deep Transcranial Magnetic Stimulation system is used to deliver magnetic field pulses to the front of the brain, altering brain activity in the process. It is non-invasive and the therapy is delivered over a number of sessions throughout approximately ten weeks. It already has FDA clearance to treat drug resistant depression and pain related to certain migraine headaches, and European CE Mark for autism, Alzheimer’s, bipolar disorder, chronic pain, major depressive disorder, Parkinson’s, schizophrenia, and other brain related disorders.
In order to verify its effectiveness for OCD, the Brainsway stimulation system was put through a multicenter clinical trial that led to the latest clearance. No serious side effects were reported and the most common adverse reaction was headaches. Interestingly, the sham control group had about the same rate of headaches as the group receiving treatment (35.3% vs 37.5%).
Here are some more details about the study, according to the company:
The multicenter study demonstrated that after six weeks of treatment, there was a statistically significant improvement in the primary endpoint results for the active treatment group when compared to sham (p=0.0127). The improvement was maintained one month after the end of treatment at week 10. The primary outcome measure of this study was the OCD Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the gold standard measure of OCD symptoms severity. Importantly, 38.1% of patients in the active group achieved a response of more than 30% reduction in symptoms severity as measured by Y-BOCS, compared with just 11.1% in the sham group (p=0.0033). Moreover, 54.8% of patients in the active group achieved a partial response of more than 20% reduction in symptoms severity, versus just 26.7% in the sham group (p=0.0076).
Here’s a Brainsway video about its technology and how it’s used to treat depression:
Product page: BrainsWay for OCD…