BrainsWay Ltd. announced preliminary positive results on June 11, 2025, from a multicenter, randomized controlled trial evaluating an accelerated Deep TMS protocol for Major Depressive Disorder (MDD). The study, titled "Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial," enrolled 104 adult patients across eight sites. This trial is the largest randomized, controlled, blinded, multicenter study of an accelerated Deep TMS protocol.
The results indicated that the accelerated Deep TMS protocol, utilizing intermittent theta burst stimulation (iTBS), yielded outcomes comparable to the standard once-daily TMS protocol. The accelerated regimen involved five sessions per day over six treatment days, followed by eight sessions over four weeks, significantly reducing treatment burden. The primary endpoint measured changes in depressive symptoms using the HDRS-21 scale.
This accelerated treatment approach has the potential to improve patient convenience and accessibility to Deep TMS therapy. While the accelerated protocol is currently investigational and not yet FDA-cleared, these preliminary findings support its efficacy. The company is committed to expanding access to Deep TMS through such advancements in care delivery.
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