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Dorsomedial prefrontal cortex repetitive transcranial magnetic stimulation for treatment-refractory major depressive disorder: A three-arm, blinded, randomized controlled trial
Brain Stimulation ( IF 7.6 ) Pub Date : 2020-03-01 , DOI: 10.1016/j.brs.2019.10.020
Katharine Dunlop 1 , Jack Sheen 2 , Laura Schulze 2 , Peter Fettes 2 , Farrokh Mansouri 3 , Kfir Feffer 4 , Daniel M Blumberger 5 , Zafiris J Daskalakis 5 , Sidney H Kennedy 6 , Peter Giacobbe 7 , Blake Woodside 8 , Jonathan Downar 9
Affiliation  

BACKGROUND Dorsomedial prefrontal cortex (DMPFC) repetitive transcranial magnetic stimulation (rTMS) is a novel intervention for treatment-refractory depression (TRD). To date, many open-label case series and one randomized controlled trial of modest sample size have provided preliminary evidence that DMPFC-rTMS is an effective treatment for TRD. Here, we report the results of a large, double-blinded, sham-controlled trial of DMPFC-rTMS for TRD. OBJECTIVE The primary aim of this study was to determine the efficacy of DMPFC-rTMS for TRD under sham-controlled conditions. METHODS 120 TRD patients were randomized to receive 30 twice-daily sessions of either active high-frequency, active low-frequency, or sham DMPFC-rTMS using a novel bent active/sham double-cone coil. Placebo stimulation also involved the use of surface electrodes placed above the eyebrows. The 17-item Hamilton Rating Scale for Depression served as the primary outcome measure. RESULTS Although there was a significant main effect of treatment across all arms, active DMPFC-rTMS was not superior to sham. Both participants and assessors were unable to accuracy determine whether patients received active or placebo stimulation. However, technicians' treatment arm guesses were significantly above chance. CONCLUSION DMPFC rTMS did not result in improvement of depressive symptoms greater than sham stimulation. We cannot rule out that the sham apparatus may also have elicited an antidepressant effect via electrical trigeminal stimulation; future DMPFC-rTMS trials are therefore warranted.

中文翻译:

背内侧前额叶皮层重复经颅磁刺激治疗难治性重度抑郁症:一项三臂、盲法、随机对照试验

背景背内侧前额叶皮层 (DMPFC) 重复经颅磁刺激 (rTMS) 是治疗难治性抑郁症 (TRD) 的新型干预措施。迄今为止,许多开放标签病例系列和一项中等样本量的随机对照试验提供了初步证据,表明 DMPFC-rTMS 是治疗 TRD 的有效方法。在这里,我们报告了一项针对 TRD 的 DMPFC-rTMS 大型、双盲、假对照试验的结果。目的 本研究的主要目的是确定 DMPFC-rTMS 在假手术控制条件下对 TRD 的疗效。方法 120 名 TRD 患者随机接受 30 次每天两次的主动高频、主动低频或使用新型弯曲主动/假双锥线圈的假 DMPFC-rTMS。安慰剂刺激还涉及使用放置在眉毛上方的表面电极。17 项汉密尔顿抑郁量表作为主要结局指标。结果 尽管所有组的治疗都有显着的主效应,但主动 DMPFC-rTMS 并不优于假手术。参与者和评估者都无法准确确定患者是接受了主动刺激还是安慰剂刺激。然而,技术人员的治疗臂猜测明显高于偶然。结论 DMPFC rTMS 没有导致抑郁症状的改善大于假刺激。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。17 项汉密尔顿抑郁量表作为主要结局指标。结果 尽管所有组的治疗都有显着的主效应,但主动 DMPFC-rTMS 并不优于假手术。参与者和评估者都无法准确确定患者是接受了主动刺激还是安慰剂刺激。然而,技术人员的治疗臂猜测明显高于偶然。结论 DMPFC rTMS 没有导致抑郁症状的改善大于假刺激。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。17 项汉密尔顿抑郁量表作为主要结局指标。结果 尽管所有组的治疗都有显着的主效应,但主动 DMPFC-rTMS 并不优于假手术。参与者和评估者都无法准确确定患者是接受了主动刺激还是安慰剂刺激。然而,技术人员的治疗臂猜测明显高于偶然。结论 DMPFC rTMS 没有导致抑郁症状的改善大于假刺激。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。主动 DMPFC-rTMS 并不优于假手术。参与者和评估者都无法准确确定患者是接受了主动刺激还是安慰剂刺激。然而,技术人员的治疗臂猜测明显高于偶然。结论 DMPFC rTMS 没有导致抑郁症状的改善大于假刺激。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。主动 DMPFC-rTMS 并不优于假手术。参与者和评估者都无法准确确定患者是接受了主动刺激还是安慰剂刺激。然而,技术人员的治疗臂猜测明显高于偶然。结论 DMPFC rTMS 没有导致抑郁症状的改善大于假刺激。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。我们不能排除假装置也可能通过三叉神经电刺激引起抗抑郁作用;因此,未来的 DMPFC-rTMS 试验是有必要的。
更新日期:2020-03-01
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