Publication & Date:The World of Biological Psychiatry 12:119-126 (2011) Investigators:E.V Harel, A Zangen, Y Roth, I Reti, Y Braw, Y LevkovitzRead 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 D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
Bipolar depression (BD) is a highly prevalent condition with limited therapeutic options. Deep (H1-coil) transcranial magnetic stimulation(dTMS) is a novel TMS modality with established efficacy for unipolar depression.
This study was a randomized sham-controlled trial to evaluate the efficacy and safety of dTMS in treatment-resistant BD patients.
Fifty patients received 20 sessions of active or sham dTMS over theleft dorsolateral prefrontal cortex (H1-coil, 55 18 Hz 2 s 120% MT trains). The primary outcome was changes in the 17-item HamiltonDepression Rating Scale (HDRS-17) from baseline to endpoint (week 4). Secondary outcomes were changes from baseline to the end ofthe follow-up phase (week 8), and response and remission rates. Safety was assessed using a dTMS adverse effects questionnaireand theYoung Mania Rating Scale to assess treatment-emergent mania switch (TEMS).
Out of 50 patients, 43 finished the trial. There were 2 and 5 dropouts in the sham and active groups, respectively. Active dTMSwas superior to sham at end point (difference favoring dTMS=4.88; 95% CI 0.43 to 9.32, p=0.03) but not at follow-up. There was also a trend for greater response rates in the active (48%) vs sham (24%) groups (OR=2.92; 95% CI=0.87 to 9.78, p=0.08). Remission rates were not statistically different. No TEMS episodes were observed.
Deep TMS is a potentially effective and well-tolerated add-on therapy in resistant bipolar depressed patients receiving adequate pharmacotherapy.