(Media News, Flickr)
20 August 2018. A non-invasive device using magnetic waves that penetrate the brain to treat obsessive-compulsive disorder received authorization for sales in the U.S. from the Food and Drug Administration. The agency on Friday announced its clearance of the device, made by Brainsway Ltd., an Israeli medical device company with offices in Hackensack, New Jersey.
Obsessive-compulsive disorder is a common and chronic condition characterized by uncontrollable thoughts, fears, and mental images that cause anxiety. But these repeated and upsetting thoughts often result in disturbing and disruptive behaviors when they involve other people. Unreasonable concern of contamination, for example, can lead to excessive and repeated hand-washing, or excessive fears can result in aggressive behaviors toward other people or oneself. FDA cites data from National Institute of Mental Health showing that 1 percent of adults in the U.S. experienced obsessive-compulsive disorder in the past year, with medication and psychotherapy the most common treatments.
Brainsway’s system uses what the company calls deep transcranial magnetic stimulation that sends electromagnetic waves into the frontal lobes of the brain. The core of the device is its own H7 coil that Brainsway says reaches deeper into the brain to stimulate nerve cells than other external stimulation devices, aiming in this case at the anterior cingulate cortex that connects the limbic system affecting emotions and the prefrontal cortex, the brain’s cognitive region. Treatments with the system last about 20 minutes and are given under supervision in a clinic. The company says it licenses its technology from patents filed by National Institutes of Health in the U.S., as well as its own intellectual property.
FDA based its authorization in part on a clinical trial of 100 individuals in North America and Israel with obsessive-compulsive disorder randomly assigned to receive either deep transcranial magnetic stimulation or sham treatments with a similar-looking but non-working device. Participants received these treatments for 6 weeks, and were evaluated for obsessive-compulsive behaviors on a standard 10-item rating scale. The results show 38 percent of participants receiving deep transcranial magnetic stimulation reported more than a 30 percent reduction in symptoms, compared to 11 percent of those receiving the sham treatments.
In addition, more than half (55%) of participants receiving Brainsway treatments experienced at least 20 percent fewer symptoms, compared to 27 percent of those in the sham treatment group. Reports of fewer symptoms among Brainsway-treated participants continued in a follow-up assessment 4 weeks later. The most common adverse effect was headache reported by about equal percentages of the Brainsway (38%) and sham treatment (35%) participants; noise made by the device requires the recipient to wear earplugs while in use. No serious adverse effects were reported.
FDA authorized the Brainsway system under its de novo premarket review pathway for new types of low- to moderate-risk medical devices. In addition to FDA clearance, the device also has a CE mark which permits marketing in Europe for a number of neurological disorders. The agency previously cleared a similar Brainsway system to treat major depressive disorder in 2008 and expanded that authorization to include pain from some forms of migraine headache in 2013.
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