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Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial
Brain Stimulation ( IF 7.6 ) Pub Date : 2021-07-29 , DOI: 10.1016/j.brs.2021.07.018
Leo Chen 1 , Elizabeth H X Thomas 2 , Pakin Kaewpijit 3 , Aleksandra Miljevic 4 , Rachel Hughes 4 , Lisa Hahn 5 , Yuko Kato 5 , Shane Gill 5 , Patrick Clarke 5 , Felicity Ng 6 , Tom Paterson 6 , Andrew Giam 7 , Shanthi Sarma 8 , Kate E Hoy 4 , Cherrie Galletly 9 , Paul B Fitzgerald 4
Affiliation  

Introduction

Theta burst pattern repetitive transcranial magnetic stimulation (TBS) is increasingly applied to treat depression. TBS's brevity is well-suited to application in accelerated schedules. Sizeable trials of accelerated TBS are lacking; and optimal TBS parameters such as stimulation intensity are not established.

Methods

We conducted a three arm, single blind, randomised, controlled, multi-site trial comparing accelerated bilateral TBS applied at 80 % or 120 % of the resting motor threshold and left unilateral 10 Hz rTMS. 300 patients with treatment-resistant depression (TRD) were recruited. TBS arms applied 20 bilateral prefrontal TBS sessions over 10 days, while the rTMS arm applied 20 daily sessions of 10 Hz rTMS to the left prefrontal cortex over 4 weeks. Primary outcome was depression treatment response at week 4.

Results

The overall treatment response rate was 43.7 % and the remission rate was 28.2 %. There were no significant differences for response (p = 0.180) or remission (p = 0.316) across the three groups. Response rates between accelerated bilateral TBS applied at sub- and supra-threshold intensities were not significantly different (p = 0.319). Linear mixed model analysis showed a significant effect of time (p < 0.01), but not rTMS type (p = 0.680).

Conclusion

This is the largest accelerated bilateral TBS study to date and provides evidence that it is effective and safe in treating TRD. The accelerated application of TBS was not associated with more rapid antidepressant effects. Bilateral sequential TBS did not have superior antidepressant effect to unilateral 10 Hz rTMS. There was no significant difference in antidepressant efficacy between sub- and supra-threshold accelerated bilateral TBS.



中文翻译:

加速θ爆发刺激治疗抑郁症:一项随机对照试验

介绍

Theta 爆发模式重复经颅磁刺激 (TBS) 越来越多地应用于治疗抑郁症。TBS 的简洁性非常适合在加速时间表中应用。缺乏加速 TBS 的大规模试验;刺激强度等最佳 TBS 参数尚未确定。

方法

我们进行了一项三臂、单盲、随机、对照、多站点试验,比较了在静息运动阈值的 80% 或 120% 下应用的加速双侧 TBS 和左侧单侧 10 Hz rTMS。招募了 300 名难治性抑郁症 (TRD) 患者。TBS 臂在 10 天内应用 20 次双侧前额叶 TBS 会话,而 rTMS 臂在 4 周内对左侧前额叶皮层每天应用 20 次 10 Hz rTMS。主要结果是第 4 周的抑郁症治疗反应。

结果

总体治疗反应率为43.7%,缓解率为28.2%。三组之间的反应( p = 0.180)或缓解(p = 0.316)没有显着差异。在亚阈值和超阈值强度下应用的加速双边 TBS 之间的响应率没有显着差异 ( p = 0.319)。线性混合模型分析显示时间的显着影响(p  < 0.01),但不是 rTMS 类型(p  = 0.680)。

结论

这是迄今为止最大的加速双边 TBS 研究,并提供证据表明它在治疗 TRD 方面是有效和安全的。TBS 的加速应用与更快速的抗抑郁作用无关。双侧顺序 TBS 没有优于单侧 10 Hz rTMS 的抗抑郁作用。亚阈值和超阈值加速双侧 TBS 之间的抗抑郁疗效没有显着差异。

更新日期:2021-08-03
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