This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
Preliminary Results Show Deep TMS to be Effective & Safe as an Add-On Treatment for Chronic Migraines
JERUSALEM – Brainsway® Ltd (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced the results of research that studied the efficacy of Brainsway Deep TMS treatment for chronic migraines. The study was initiated by researchers from Sapienza University in Rome, and published by Head Researcher Prof. Antonio Del Casale. The study was held with no involvement on the part of the company.
This study comprised 14 patients who met standard criteria and were defined as suffering from chronic migraine at the beginning of the study. All participants were suffering headaches at least 15 days a month, which significantly impaired their functioning and quality of life, and who did not respond to three different types of treatments (or more).
During the 4 weeks of the treatment, the patients continued taking medication, but 7 of them (the treatment group) also received 12 days of Deep TMS treatment at a high frequency (10 Hz) using the H1 coil. The Deep TMS treatment was performed in a bilateral mode to the prefrontal area (DLPFC) with a higher intensity on the left side of the brain. The Deep TMS effect was studied using standard rating scales before, during, and a month after the treatment. During the study, no side effects were observed.
The results of the study showed a significant and statistically distinct reduction in the headaches, in their frequency, in the overuse of painkillers, and in the depressive symptoms of the Study group, compared to the Sham group and the ratings taken before the study. This decrease was observed during the study and was still intact a month later.
The researchers concluded that stimulation using the company device is effective and safe as an add-on treatment to medication in patients suffering from chronic migraines.
Dr. Guy Ezekiel, Brainsway CEO, said: “This group of researchers approached us several years ago with a request for funding research in the field of migraines, claiming that Brainsway’s prefrontal coil for depression could be effective for migraines, when combined with medication. Brainsway did not fund this research or the device for it, but the researchers purchased the device independently, and proved their claim in a small-scale research, in an impressive and convincing way.”
Brainsway handles research, development and marketing of a medical system for noninvasive treatment in prevalent brain disorders. The medical device developed and manufactured by the company is based on a unique revolutionary technology called Deep TMS, which enables reaching deep areas in the brain and creating neutral stimulation or inhibition. The company’s systems are sold worldwide, are cleared by the CE and FDA, and feature reimbursement covering 85% of US population. The main company efforts are currently focused on commercialization and deepening of penetration to the US market for Treatment Resistant Depression.
Read the original aritcle in Hebrew here.