Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.
Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.
Brain Stimul. 2024 Jul-Aug;17(4):760-768. doi: 10.1016/j.brs.2024.06.004. Epub 2024 Jun 14.
The effect of transcranial alternating current stimulation (tACS) on major depressive disorder (MDD) was not confirmed.
To evaluate the feasibility, safety, and efficacy of tACS as an add-on treatment for the symptoms of depression and to understand how tACS affects brain activity.
The 4-week, double-blind, randomized, sham-controlled trial was performed from January 29, 2023 to December 22, 2023. Sixty-six participants were recruited and randomly assigned to receive 20 40-min sessions of either active (77.5Hz, 15 mA) or sham stimulation, with one electrode on the forehead and two on the mastoid, each day (n = 33 for each group) for four weeks (till Week 4). The participants were followed for 4 more weeks (till Week 8) without stimulation for efficacy/safety assessment. During the 4-week trial, all participants were required to take 10-20 mg of escitalopram daily. The primary efficacy endpoint was the change in HAMD-17 scores from baseline to Week 4 (with 20 treatment sessions completed). Resting-state electroencephalography (EEG) was collected with a 64-channel EEG system (Brain Products, Germany) at baseline and the Week 4 follow-up. The chi-square test, Fisher's exact test, independent-sample t-test, or Wilcoxon rank-sum test were used, as appropriate, to compare the differences in variables between groups. The effect of the intervention on the HAMD-17 score was also evaluated with linear mixed modeling (LMM) as sensitivity analysis. The correlation between the mean reduction in EEG and the mean reduction in the HAMD-17 total score was evaluated using Spearman correlation analysis.
A total of 66 patients (mean [SD] age, 28.4 [8.18] years; 52 [78.8 %] female) were randomized, and 57 patients completed the study. Significant differences were found in the reductions in the HAMD-17 scores at Week 4 (t = 3.44, P = 0.001). Response rates at Week 4 were significantly higher in the active tACS group than in the sham tACS group (22 out of 33 patients [66.7 %] versus 11 out of 33 [33.3 %], P = 0.007). In the active tACS group, a correlation between the mean change in alpha power and HAMD-17 scores at Week 4 was found (r = 2.38, P = 0.024), and the mean change in alpha power was significantly bigger for responders (Z = 2.46, P = 0.014). No serious adverse events were observed in this trial.
The additional antidepressant effect of tACS is significant, and the combination of tACS with antidepressants is a feasible and effective approach for the treatment of MDD. The antidepressant mechanism of tACS may be the reduction in alpha power in the left frontal lobe. Future research directions may include exploring more appropriate treatment parameters of tACS.
经颅交流电刺激（tACS）对重度抑郁症（MDD）的疗效尚未得到证实。
评估 tACS 作为附加治疗对抑郁症状的可行性、安全性和疗效，并了解 tACS 如何影响大脑活动。
该 4 周、双盲、随机、假对照试验于 2023 年 1 月 29 日至 2023 年 12 月 22 日进行。招募了 66 名参与者，并随机分配接受 20 次 40 分钟的积极（77.5Hz，15mA）或假刺激，前额一个电极，乳突两个电极，每天一次（每组 33 名），持续四周（直到第 4 周）。在接下来的 4 周（直到第 8 周）没有刺激进行疗效/安全性评估。在 4 周的试验期间，所有参与者都需要每天服用 10-20mg 的依地普仑。主要疗效终点是从基线到第 4 周（完成 20 次治疗）HAMD-17 评分的变化。在基线和第 4 周随访时使用 64 通道脑电图（EEG）系统（德国 Brain Products）采集静息态 EEG。使用卡方检验、Fisher 确切检验、独立样本 t 检验或 Wilcoxon 秩和检验，根据需要比较组间变量的差异。还使用线性混合模型（LMM）评估干预对 HAMD-17 评分的影响作为敏感性分析。使用 Spearman 相关分析评估 EEG 平均降低量与 HAMD-17 总分平均降低量之间的相关性。
共 66 名患者（平均[SD]年龄，28.4[8.18]岁；52[78.8%]女性）被随机分配，57 名患者完成了研究。第 4 周 HAMD-17 评分的降低有显著差异（t=3.44，P=0.001）。第 4 周时，积极 tACS 组的应答率明显高于假 tACS 组（33 名患者中有 22 名[66.7%]与 33 名患者中有 11 名[33.3%]，P=0.007）。在积极 tACS 组中，发现第 4 周时 alpha 功率的平均变化与 HAMD-17 评分之间存在相关性（r=2.38，P=0.024），并且应答者的 alpha 功率平均变化更大（Z=2.46，P=0.014）。在这项试验中没有观察到严重的不良事件。
tACS 的附加抗抑郁作用显著，tACS 联合抗抑郁药是治疗 MDD 的一种可行有效的方法。tACS 的抗抑郁机制可能是左额叶 alpha 功率的降低。未来的研究方向可能包括探索更合适的 tACS 治疗参数。
