FDA approves device to treat obsessive-compulsive disorder
The Food and Drug Administration has cleared a device that uses magnetic fields to stimulate nerve cells in the brain for the treatment of a common mental illness.
The procedure, called transcranial magnetic stimulation, was approved by the FDA as a treatment for major depression in 2008. The regulatory agency subsequently expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.
Now, the FDA has decided to permit the marketing of the Deep Transcranial Magnetic Stimulation System from Israeli vendor Brainsway for obsessive-compulsive disorder (OCD), based on the agency’s review of data from a randomized, multi-center study of 100 patients.
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” says Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”
OCD is typically treated with medication, psychotherapy or both. However, while most patients respond to treatment, some continue to experience uncontrollable, reoccurring thoughts and behaviors that they feel the urge to repeat over and over.
The study of the Brainsway device assessed the reduction in patients’ Yale-Brown Obsessive Compulsive Scale score, which measures the severity of a patient’s OCD. The results showed that 38 percent of patients responded to the Brainsway device—greater than 30 percent reduction in YBOCS score—while 11 percent of patients responded when using a sham device.
“The most frequent adverse reaction was headache, reported by 37.5 percent of the patients who received the Brainsway device and by 35.3 percent of the patients who received the sham treatment,” according to the FDA. “No serious adverse reactions related to the Brainsway device were reported. Other adverse reactions, such as application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching and neck pain, were reported as either mild or moderate and resolved shortly after treatment.”
The agency also noted that patients must use earplugs to reduce exposure to the loud sounds produced by the device, while those with a history of seizures should discuss it with their provider before being treated.
The Brainsway device was reviewed by the FDA through its de novo premarket review pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.