Washington, DC - Friday, the U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD).
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, Ph.D., M.S., 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 a common, chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts and behaviors that a person feels the urge to repeat over and over. OCD is typically treated with medication, psychotherapy or a combination of the two. According to the National Institute of Mental Health, about 1 percent of U.S. adults had OCD in the past year. Although most patients with OCD respond to treatment, some patients continue to experience symptoms.
Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain. The FDA permitted marketing of TMS as a treatment for major depression in 2008 and expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.
The FDA reviewed data from a randomized, multi-center study of 100 patients, of which 49 patients received treatment with the Brainsway device and 51 received treatment with a non-working (sham) device. Patients already receiving OCD treatments (medical management) were maintained at their current dosages throughout the study. The study evaluated the reduction in patients’ Yale-Brown Obsessive Compulsive Scale (YBOCS) score, a common metric for measuring the severity of a patient’s OCD. The results indicated that 38 percent of patients responded to the Brainsway device (i.e., greater than 30 percent reduction in YBOCS score), whereas 11 percent of patients responded when using the 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. 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 Brainsway device is contraindicated for patients with metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. During treatment with the device, the patient must use earplugs to reduce exposure to the loud sounds produced by the device. Patients with a history of seizures should discuss their history with their health care provider before receiving the device.
The FDA reviewed the Brainsway device through the de novo premarket review pathway, a regulatory 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.
The FDA permitted marketing of the Brainsway device to Brainway Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.