Transcranial Magnetic Stimulation Device Approved for OCD Patient Marketing

The US Food and Drug Administration (FDA) has permitted marketing for the Brainsway Deep Transcranial Magnetic Stimulation System, a device designed to treat patients with obsessive compulsive disorder (OCD).

Transcranial magnetic stimulation (TMS), a procedure that stimulates nerve cells in the brain through magnetic fields, was originally permitted marketing as a major depression therapy in 2008. Five years later, the FDA expanded its use to include the treatment of pain associated with migraine headaches.

For this indication, the FDA had reviewed the data from a randomized, multi-center study involving 100 patients with OCD split evenly to receive treatment either with TMS (n= 49) or a sham device (n= 51).

Investigators maintained therapy for patients already prescrived OCD treatments throughout the trial, while evaluating for reductions in Yale-Brown Obsessive Compulsive Scale (YBOCS), a fairly common metric to gauge severed OCD. According to their results, 38% of patients responded to the TMS device with a YBOCS score reduction greater than 30%. Just 11% of patients treated with a sham device reported such a reduction.

OCD, a chronic disorder which results in uncontrollable and reoccurring thoughts and behaviors that urge people to repeatedly perform tasks, is commonly treated with medicines, psychotherapy, or some combination of the pair. The National Institute of Mental Health reports that about 1% of US adults had OCD last year.

Carlos Pena, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, emphasized the potential of the Brainsway device for OCD.

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” Pena said in a statement. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”

The FDA had reviewed the Brainsway device through the de novo premarket review pathway, designated for low- to moderate-risk novel devices for which there are no marketed devices to which the device can claim substantial equivalence.