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: Depression and Anxiety 27:465-469 (2010)
Authors: T.S Kaster, Z.J Daskalakis, Y Noda, Y Knyahnystska, J Downar, T.K Rajji, Y Levkovitz, A Zangen, M.A Butters, B.H Mulsant, D.M Bumberger
Late-life depression (LLD) is a growing worldwide problem due to demographic changes, with limited treatment options due to high rates of pharmacotherapy adverse effects, accessibility of psychotherapy, and tolerability of electroconvulsive therapy. Novel neuromodulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), may overcome these limitations.
The objective of this study was to determine the efficacy, tolerability, and cognitive effects of high-dose deep rTMS in LLD.
Fifty-two participants, aged 60-85 years old, with major depressive disorder (MDD)were randomized to active (n=25) or sham (n=27) deep rTMS (H1 coil, 6012 pulses, 18Hz, 120% of resting motor threshold) delivered over the dorsolateral and ventrolateral prefrontal cortex five days per week over four weeks. The primary outcome was remission of depression in an intention to treat analysis. Change in cognitive functioning with rTMS treatment and tolerability based on adverse effects were also assessed.
Remission rate was significantly higher with active than sham rTMS (40.0% vs 14.8%) with a number needed to treat of 4.0 (95% CI:2.1-56.5). There was no change on any measure of executive function and no serious adverse events. Adverse effect profiles were similar between active and sham rTMS, except for reports of pain being significantly more common in the active condition (16.0% vs 0%).
High-dose deep rTMS appears to be safe, well tolerated, and efficacious in the treatment of LLD.