FDA Clears Brain Stimulation Device for OCD

Megan Brooks

Disclosures

August 17, 2018

The US Food and Drug Administration (FDA) granted marketing approval for the Brainsway deep transcranial magnetic stimulation (dTMS) system (Brainsway Ltd) for treatment of obsessive-compulsive disorder (OCD).

OCD, which affects around 6 million US adults in any given year, is typically treated with medication, psychotherapy, or a combination of the two, although some patients continue to experience symptoms.

"Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches. With today's marketing authorization, patients with OCD who have not responded to traditional treatments now have another option," Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in a news release.

TMS uses magnetic fields to stimulate nerve cells in the brain. The FDA previously approved TMS as a treatment option for major depression and migraine headache.

In approving the Brainsway dTMS system, the FDA reviewed data from a randomized, multicenter study of 100 patients, of whom 49 received treatment with the Brainsway device and 51 received treatment with a sham device. All patients were maintained on their current OCD treatments.

The study evaluated the reduction in patients' Yale-Brown Obsessive Compulsive Scale (YBOCS) score. Results showed that 38% of patients responded to the Brainsway device, with a >30% reduction in YBOCS score, compared with 11% of patients who used the sham device.

The most common adverse reaction was headache, reported by 37.5% of the patients who received the Brainsway device and by 35.3% of the patients who received 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 in intensity and resolved shortly after treatment.

The FDA says the Brainsway TMS system should not be used in 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 wear earplugs to reduce exposure to the loud sounds produced by the device. Patients with a history of seizures should discuss their history with their healthcare provider before receiving the device, the FDA advises.

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.

 

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