Levkovitz, Y., Harel, E. V., Roth, Y., Braw, Y., Most, D., Katz, L. N., & Zangen, A. (2009). Brain Stimulation, 2(4), 188-200. This is the first clinical study using the Brainsway® Deep TMS (Tr...Read More
This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
Journal: Brain Stimulation 10:355 (2017)
Authors: K.K Kedzior, C Müller, L Gerkensmeier, H.M Gellersen, M Schuchinsky
Deep transcranial magnetic stimulation (dTMS) is a non-invasive brain stimulation method approved by the FDA as a therapy for treatment-resistant major depressive disorder.
The aim of this study was to evaluate the clinically-relevant outcomes of daily dTMS treatment in unipolar major depression using a systematic review and meta-analysis.
Following a systematic literature search of Psyc Info and Medline (any date till 24.06.2016), k=9 studies (k=8 open-label and k=1 double-blind randomized controlled trial, RCT, with an inactive sham group) were included in the current study. The outcomes were standardised change scores (Hedges’g) in depression severity on Hamilton Depression Rating Scale (HDRS), response, remission, and dropout rates, and several cognitive functions after daily dTMS compared to baseline. Effect sizes were pooled according to a random-effects meta-analysis with inverse-variance weights.
The nine studies included 229 patients with treatment-resistant unipolar major depression (according to DSM-IV) at baseline (n=128 in open-label studies and n=101 in RCT/active dTMS group only). dTMS was administered with H1-coil as a high-frequency (18-20 Hz) and high intensity (120% of the resting motor threshold) stimulation with 33,600-60,000 stimuli over 20 daily sessions. dTMS significantly reduced depression severity ink=8 open-label studies (Hedges’g=1.74, 95%CI:1.35-2.13). The pooled response, remission, and dropout rates were 56%,30%, and 21% respectively ink=8 open-label studies, and 38%, 33%, and 8%, respectively in the RCT (active dTMS group only). Of the 44 dropouts, two patients reported suicidal ideation and two patients experienced a seizure. Visuospatial memory improved significantly after dTMS relative to base-line in two out of three open-label studies with cognitive data.
High-frequency dTMS appears to improve clinical symptoms and some cognitive functions in treatment-resistant unipolar major depression. Future head-to-head studies are required to compare the clinical efficacy of dTMS with other brain stimulation methods.