The FDA has announced that it will enable the marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for the treatment of obsessive compulsive disorder (OCD).
According to the National Institute of Mental Health, about 1 percent of US adults had OCD in the past year. Although most patients with OCD respond to treatment, some patients continue to experience symptoms.
The FDA allowed the marketing of transcranial magnetic stimulation (TMS) as a treatment for severe depression in 2008 and expanded its use for the treatment of pain associated with certain migraine headaches in 2013.
The FDA reviewed data from a randomized, multi-center study of 100 patients, 49 of whom received treatment with the Brainsway device; 51 patients received treatment with a sham. Patients who have already received OCD treatments (medical management) were kept at their current doses throughout the study. The study evaluated the reduction of the Yale-Brown Obsessive Compulsive Scale (YBOCS) score, a common measure for measuring the severity of a patient's OCD. The results indicated that 38 percent of patients responded to the Brainsway device (i.e., more than 30 percent reduction in YBOCS score), while 11 percent of patients responded when using the apparent device.
The most common side effect was headache, which was reported by 37.5 percent of patients receiving the Brainsway device and by 35.3 percent of patients who received the sham treatment. No serious adverse reactions have been reported related to the Brainsway device. Other side effects, such as pain in the workplace or discomfort, jaw pain, facial pain, muscle pain, spasms or twitching and neck pain, were reported as mild or moderate and disappeared shortly after treatment.
Source: FDA.gov, 17 August 2018