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经颅交流电刺激治疗首发成年重度抑郁症患者的一项初步研究

[A pilot study of transcranial alternating current stimulation in the treatment of drug-naive adult patients with major depressive disorder].

作者信息

Wang H X, Wang K, Sun Z C, Peng M, Xue Q, Li N, Min B Q, Dong K, Zhang Q, Zhan S Q, Fan C Q, Zhou A H, Jia Y, Du J L, Zhou Q L, Xu Z X, Song H Q, Wang Y P

机构信息

Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2020 Jan 21;100(3):197-201. doi: 10.3760/cma.j.issn.0376-2491.2020.03.008.

Abstract

To explore the efficacy, adverse reactions, feasibility, and acceptability of transcranial alternating current stimulation (tACS) treating drug-naive adult patients with major depressive disorder (MDD), and provide basis for further study with a large sample. The study was performed in the Neuromodulation laboratory, Department of Neurology of Xuanwu Hospital, Capital Medical University (Beijing, China) from July, 2017 to June, 2018. Thirty Eligible first-episode MDD outpatients were randomized 1∶1 to receive active tACS or sham intervention. The tACS was administered in a 40 minute, 77.5 Hz frequency, 15 mA session with one forehead (Fp1, Fpz, and Fp2, in the 10/20 international placement system, 4.45 cm×9.53 cm) and two mastoid (3.18 cm×3.81 cm) stimulation for 20 times in 4 consecutive weeks at fixed day time frame once daily from Monday through Friday, with weekends off (week 4), followed by 4 weeks with no tACS treatment (week 8). By utilizing the Hamilton rating scale for depression-17 item (HRSD-17) to assess the depressive severity of MDD patients, adverse events were administered by the treatment-emergent adverse events, the Young mania rating scale, and the self-made common questionnaire on cranial electrical stimulation. The primary efficacy outcome was the remission rate defined as HRSD-17 score ≤7 at week 8. Secondary outcomes included the rates of remission at week 4 and response at weeks 4 and 8. Safety was assessed by evaluation of adverse events. Also the proportions of participants accepting the intervention and this study procedure were evaluated at weeks 4 and 8. Thirty MDD patients completed the study, and both groups had no statistical differences on their demographic characteristics (0.05). At week 8, the active group had a remission rate of 10/15, which was higher than 3/15 in the sham group (0.05). Also, the remission rate (14/15) in the active group was higher than 5/15 of the sham group at week 4 (0.05). For the response rates, significant differences were found between groups at week 8. For safety, both groups showed no severe adverse events and no mania/hypomania. One participant per group had 2 times of tinnitus cerebri during the intervention days. All patients accepted the intervention and the study procedure. The pilot study indicated that tACS with 77.5 Hz and 15 mA may have a therapeutic effect on depressive symptoms. It is well-tolerated and safe, as well as feasible and acceptable for adults with MDD.

摘要

探讨经颅交流电刺激(tACS)治疗未服用过药物的成年重度抑郁症(MDD)患者的疗效、不良反应、可行性和可接受性,为进一步开展大样本研究提供依据。该研究于2017年7月至2018年6月在首都医科大学宣武医院神经内科神经调控实验室(中国北京)进行。30例符合条件的首发MDD门诊患者按1∶1随机分组,分别接受主动tACS或假干预。tACS治疗采用频率77.5Hz、电流15mA、时长40分钟的刺激,在10/20国际电极放置系统中,对前额一个部位(Fp1、Fpz和Fp2,面积4.45cm×9.53cm)和两个乳突部位(面积3.18cm×3.81cm)进行刺激,连续4周,每周一至周五每天固定时间进行1次,共20次,周末休息(第4周),之后4周不进行tACS治疗(第8周)。采用汉密尔顿抑郁量表17项版(HRSD - 17)评估MDD患者的抑郁严重程度,通过治疗中出现的不良事件、杨氏躁狂量表及自制的经颅电刺激通用问卷记录不良事件。主要疗效指标为第8周时HRSD - 17评分≤7分的缓解率。次要指标包括第4周时的缓解率以及第4周和第8周时的有效率。通过评估不良事件来评价安全性。同时在第4周和第8周评估参与者接受干预及本研究程序的比例。30例MDD患者完成了研究,两组在人口统计学特征上无统计学差异(P>0.05)。第8周时,主动治疗组缓解率为10/15,高于假手术组的3/15(P<0.05)。第4周时,主动治疗组缓解率(14/15)也高于假手术组的5/15(P<0.05)。在有效率方面,两组在第8周时存在显著差异。在安全性方面,两组均未出现严重不良事件,也未出现躁狂/轻躁狂发作。每组各有1名参与者在干预期间出现2次脑鸣。所有患者均接受了干预及研究程序。该初步研究表明,77.5Hz、15mA的tACS可能对抑郁症状有治疗作用。对于成年MDD患者而言,其耐受性良好、安全,且具有可行性和可接受性。

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