Tan Xiao Wei, Abdin Edimansyah, Tor Phern Chern
Department of Mood and Anxiety, Institute of Mental Health, 10 Buangkok View, Singapore, 539747, Singapore.
Research Division, Institute of Mental Health, Singapore, 539747, Singapore.
Pilot Feasibility Stud. 2021 May 5;7(1):104. doi: 10.1186/s40814-021-00845-9.
Repetitive transcranial magnetic stimulation (rTMS) is a technique for stimulating brain activity using a transient magnetic field to induce an electrical current in the brain producing depolarization of focal groups of brain cells. TMS is a protocol approved by the U.S. Food and Drug Administration in routine clinical practice as a treatment for depression. A major limitation of rTMS is the large amount of time taken for a standard protocol (38 min a day for 20-30 working days). The optimal type and duration of TMS are still uncertain, as is the optimal strategy for continuing or changing the type of rTMS if there is a poor initial response.
The trial aims to assess whether a 1-week compressed course of left dorsolateral prefrontal (L DLPFC) 5 Hz accelerated rTMS (aTMS) treatment is as effective as an established 4-week course of non-accelerated rTMS and if additional 5 Hz L DLPFC aTMS treatments will be efficacious in non-responders as compared to 1 Hz right DLPFC aTMS treatment.
A randomized, single-blind, delayed-start trial was planned to commence in Jan 2020. A total of 60 patients will be enrolled from the Institute of Mental Health Singapore within a 2-year period and randomized into the early or delayed-start phase of the trial. The primary outcome of the trial is the improvement of Montgomery-Asberg Depression Rating scale at the end of the active treatment phase.
If this study protocol proves to be effective, the findings of this trial will be updated to the College of Psychiatrists, Academy of Medicine Singapore, as well as published in a peer-reviewed journal to enhance local and international TMS treatment guidelines.
ClinicalTrials.gov ID: NCT03941106.
重复经颅磁刺激（rTMS）是一种利用瞬态磁场刺激大脑活动的技术，通过在大脑中感应出电流，使局部脑细胞群发生去极化。经颅磁刺激是美国食品药品监督管理局批准用于抑郁症常规临床治疗的一种方案。重复经颅磁刺激的一个主要局限是标准方案所需时间较长（每天38分钟，共20 - 30个工作日）。经颅磁刺激的最佳类型和持续时间仍不确定，对于初始反应不佳时继续或改变重复经颅磁刺激类型的最佳策略也不明确。
该试验旨在评估为期1周的左侧背外侧前额叶（L DLPFC）5赫兹加速重复经颅磁刺激（aTMS）治疗疗程是否与既定的4周非加速重复经颅磁刺激疗程效果相同，以及与1赫兹右侧背外侧前额叶加速重复经颅磁刺激治疗相比，额外的5赫兹左侧背外侧前额叶加速重复经颅磁刺激治疗对无反应者是否有效。
计划于2020年1月开展一项随机、单盲、延迟启动试验。在两年内从新加坡心理健康研究所招募60名患者，并随机分为试验的早期或延迟启动阶段。试验的主要结局是在积极治疗阶段结束时蒙哥马利 - 阿斯伯格抑郁评定量表的改善情况。
如果本研究方案被证明有效，该试验结果将更新给新加坡医学科学院精神科医师学院，并发表在同行评审期刊上，以完善本地和国际经颅磁刺激治疗指南。
ClinicalTrials.gov标识符：NCT03941106。
