Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.
Stockholm Health Care Services, Region Stockholm, Karolinska University Hospital.
Medicine (Baltimore). 2021 Apr 9;100(14):e25273. doi: 10.1097/MD.0000000000025273.
The optimal dose (number of pulses per session) of repetitive transcranial magnetic stimulation (rTMS), using the H-coil, in major depressive disorder (MDD) has not previously been reported.
To explore the relationship between rTMS dose and antidepressant effect, and collect data for the design of a definitive trial.
This was a double-blind, three-arm parallel-group, randomized [1:1:1], pilot trial conducted in Stockholm, Sweden (September 2014 to September 2016). The primary outcome was change in depression severity measured with the Montgomery Åsberg Depression Rating Scale (MADRS) after 4 weeks. Participants (n = 29) with MDD were randomized to 1000, 2000, or 4000 pulses of rTMS for 20 sessions during 4 weeks.
At 4 weeks, the 3 treatment groups reduced the mean MADRS (95% CI) by 11.6 (4.0-19.2), 9.1 (5.0-13.3), and 11.3 (4.1-18.5) points respectively. Eleven participants met criteria for response and 10 for remission. No serious adverse events occurred. Ratings of subjective memory improved in all groups. Exploring the effect of dose and time, 4000 pulses had the largest reduction in MADRS during the first 2 weeks. A comparison of change in MADRS between 2000 and 4000 pulses after 2 weeks will require a sample size of 66 patients at power .80 and alpha .05.
It is feasible to conduct a definitive trial investigating whether a higher number of magnetic pulses per treatment session gives a more rapid antidepressive response.
使用 H 线圈的重复经颅磁刺激（rTMS）在重度抑郁症（MDD）中的最佳剂量（每个疗程的脉冲数）尚未报道。
探讨 rTMS 剂量与抗抑郁效果的关系，并为确证性试验设计收集数据。
这是一项在瑞典斯德哥尔摩进行的双盲、三臂平行组、随机（1:1:1）、试点试验（2014 年 9 月至 2016 年 9 月）。主要结局是 4 周后用蒙哥马利抑郁评定量表（MADRS）测量的抑郁严重程度变化。患有 MDD 的参与者（n=29）被随机分为 1000、2000 或 4000 个脉冲 rTMS，共 20 个疗程，持续 4 周。
在 4 周时，3 个治疗组的平均 MADRS（95%CI）分别降低了 11.6（4.0-19.2）、9.1（5.0-13.3）和 11.3（4.1-18.5）点。11 名参与者符合缓解标准，10 名符合缓解标准。未发生严重不良事件。所有组的主观记忆评分均有所提高。在探索剂量和时间的影响时，4000 个脉冲在前 2 周内对 MADRS 的降低作用最大。在第 2 周后，2000 个和 4000 个脉冲对 MADRS 的变化进行比较，需要在.80 功效和.05 水平下，样本量为 66 名患者。
进行一项关于每个疗程给予更多磁脉冲是否能更快产生抗抑郁反应的确证性试验是可行的。
