This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Journal: World Psychiatry 14(1):64-73 (2015)
Authors: Y Levkovitz, M Isserles, F Padberg, S.H. Lisanby, A Bystritsky, G Xia, A Tendler, Z.J Daskalakis, J.L Winston, P Dannon, H.M Hafez, I.M Reti, O.G Morales, T.E Schlaepfer, E Hollander, J.A Berman, M.M Husain, U Sofer, A Stein, S Adler, L Deutsch, F Deutsch, Y Roth, M.S George, A Zangen
Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas.
This was the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. This study led to FDA clearance of the BrainsWay dTMS device (FDA 510(k) Number K122288).
212 MDD outpatients, aged 22–68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode were recruited. They were randomly assigned to mono therapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively.
dTMS induced a 6.39 points improvement in HDRS-21 scores, while a 3.28 points improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission:32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred.
These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment.