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: CNS Spectrums 23(1): 71-72 (2018)
Authors: E.V Harel, D Shmuel, D Antler, D Katz, E Pushkarski, E Ais, A Schvartz, A Tendler, Y Roth, A Zangen, Y levkovitz
Repetitive deep transcranial magnetic stimulation (dTMS) is efficacious for treatment resistant major depressive disorder (TRD) with the H1 coil by stimulating the prefrontal cortex, left more than right, at high frequency. Theoretically, the efficacy of dTMS could be optimized by simultaneously stimulating the right and left lateral prefrontal cortices (PFC) with different frequencies.
This study tested the efficacy of a novel dual-channel dTMS stimulator with dual dTMS coils, in patients with TRD.
Forty-seven outpatients diagnosed with TRD, age 18-65, Hamilton Depression Rating Scale (HDRS-21) score ≥ 25 were recruited to the study. Each patient received 20 open label treatment sessions, five days a week for 4 consecutive weeks. Treatments were administered with the dual-channel stimulator (Brainsway Multiway dTMS device) using two channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. Primary and secondary efficacy outcome measures were the change in HDRS-21 score and response/remission rates at week 5, respectively.
The HDRS-21 score decreased from an average of 25.94 to 14.69 (P< 0.001). Thirty-six patients completed four weeks of treatment. Of them, seventeen (47%) responded (HDRS-21 score decrease of >50% from their initial score) and eight (22%) remitted (HDRS-21score of <10 at the end of the study).
This open study shows promising results for multichannel simultaneous dTMS treatment of TRD using the BrainswayMultiway Device. Further randomized controlled studies are necessary to aid the high number of patients with TRD.