Abstract
Background: Based on the finding of non-inferiority in a single large clinical trial, the FDA in 2018 cleared the MagVita (MV) device for the use of Intermittent Theta Burst Stimulation (iTBS) in the treatment of Major Depressive Disorder (MDD). This study examines the effectiveness of iTBS compared to standard rTMS (TMS) in the naturalistic setting of a community-based practice. Methods: This non-random, unblinded, retrospective review involved 786 patients with treatment-resistant MDD. 699 patients were treated with TMS to the L-DLPFC utilizing generally accepted protocols: NeuroStar (10 Hz, 3-5K pulses/treatment (PPT)), Brainsway (18 Hz, 1.98-2.7K PPT) and MagVita (10 Hz, 3-5K PPT). 87 patients were treated with iTBS on the MV device (50 Hz, 0.6-2.4K PPT), usually combined with R-DLPFC (1 Hz, 1.2 K PPT). iTBS was used for one of the following indications: intolerance of TMS, lack of response to TMS, emerging activation/anxiety with TMS or concern about induction of mania. Patients generally received a total of 30-36 sessions. Progress was tracked using the PHQ-9 and MADRS; response categories are based on generally-accepted standards. Results: Results of TMS vs iTBS, respectively, are as follows: Remission: 36% vs 24%; Full Response: 28% vs 29%; Partial Response: 17% vs 27%; Non-response: 13% vs 18%; Withdrawal: 6% vs 2%. Conclusions: The overall response rate (Remission plus Full plus Partial Response) of TMS vs iTBS was respectively 81% vs 79%, generally verifying the non-inferiority of iTBS. TMS was substantially superior to iTBS in rate of Remission but equivalent in rate of Full Response. This study is naturalistic and severely limited due to non-random, unblinded patient selection, retrospective review and the use of multiple protocols. A full statistical analysis was beyond the scope of this study. Conflicts of Interest: None to Report Funding: No external funding or other support was received.
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