Lee C W, Park K, Ahn J E, Jang Y, Park Y S, Yu H, Lee D, Ihm H K, Lee J, Kim J, Lee Y I, Lim S-E, Kwon S S, Park H Y, Ha T H, Yoon I-Y, Myung Woojae, Baek Ji Hyun
Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Center for Clinical Research, Samsung Biomedical Research Institute (SBRI), Seoul, Republic of Korea.
Eur Psychiatry. 2025 Jan 15;68(1):e15. doi: 10.1192/j.eurpsy.2024.1811.
Transcranial direct current stimulation (tDCS) is a promising treatment for major depressive disorder (MDD). This study evaluated its antidepressant and cognitive effects as a safe, effective, home-based therapy for MDD.
This double-blind, sham-controlled, randomized trial divided participants into low-intensity (1 mA, = 47), high-intensity (2 mA, = 49), and sham ( = 45) groups, receiving 42 daily tDCS sessions, including weekends and holidays, targeting the dorsolateral prefrontal cortex for 30 minutes. Assessments were conducted at baseline and weeks 2, 4, and 6. The primary outcome was cognitive improvement assessed by changes in total accuracy on the 2-back test from baseline to week 6. Secondary outcomes included changes in depressive symptoms (HAM-D), anxiety (HAM-A), and quality of life (QLES). Adverse events were monitored. This trial was registered with ClinicalTrials.gov (NCT04709952).
In the tDCS study, of 141 participants (102 [72.3%] women; mean age 35.7 years, standard deviation 12.7), 95 completed the trial. Mean changes in the total accuracy scores from baseline to week 6 were compared across the three groups using an -test. Linear mixed-effects models examined the interaction of group and time. Results showed no significant differences among groups in cognitive or depressive outcomes at week 6. Active groups experienced more mild adverse events compared to sham but had similar rates of severe adverse events and dropout.
Home-based tDCS for MDD demonstrated no evidence of effectiveness but was safe and well-tolerated. Further research is needed to address the technical limitations, evaluate broader cognitive functions, and extend durations to evaluate its therapeutic potential.
经颅直流电刺激（tDCS）是一种有前景的重度抑郁症（MDD）治疗方法。本研究评估了其作为一种安全、有效的家庭式MDD治疗方法的抗抑郁和认知效果。
这项双盲、假刺激对照、随机试验将参与者分为低强度组（1毫安，n = 47）、高强度组（2毫安，n = 49）和假刺激组（n = 45），每天接受42次tDCS治疗，包括周末和节假日，刺激背外侧前额叶皮质，每次30分钟。在基线以及第2、4和6周进行评估。主要结局是通过从基线到第6周2-back测试的总准确率变化评估的认知改善情况。次要结局包括抑郁症状（汉密尔顿抑郁量表，HAM-D）、焦虑（汉密尔顿焦虑量表，HAM-A）和生活质量（QLES）的变化。监测不良事件。本试验已在ClinicalTrials.gov注册（NCT04709952）。
在tDCS研究中，141名参与者（102名[72.3%]女性；平均年龄35.7岁，标准差12.7）中，95名完成了试验。使用t检验比较了三组从基线到第6周总准确率得分的平均变化。线性混合效应模型检验了组和时间的交互作用。结果显示，在第6周时，三组在认知或抑郁结局方面无显著差异。与假刺激组相比，活性组经历的轻度不良事件更多，但严重不良事件和退出率相似。
家庭式tDCS治疗MDD未显示出有效性证据，但安全且耐受性良好。需要进一步研究以解决技术局限性、评估更广泛的认知功能并延长疗程以评估其治疗潜力。
