Lee Jangwon, Lee Chan Woo, Jang Yoonjeong, You Ji Seon, Park Yun Seong, Ji Eunjeong, Yu Hyeona, Oh Sunghee, Ryoo Hyun A, Cho Nayoung, Park Ji Yoon, Yoon Joohyun, Baek Ji Hyun, Park Hye Youn, Ha Tae Hyon, Myung Woojae
Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seoul, South Korea.
Medical Research Collaborating Centre, Seoul National University Bundang Hospital, Seoul, South Korea.
Front Psychiatry. 2022 Sep 20;13:969199. doi: 10.3389/fpsyt.2022.969199. eCollection 2022.
Although transcranial direct current stimulation (tDCS) is known to be a promising therapeutic modality for unipolar depression, the efficacy and safety of tDCS for bipolar depressive episodes (BD) are still unknown and clinical trials of home-based tDCS treatment are scarce. As a result, we set out to investigate the efficacy and safety of home-based tDCS for the treatment BD.
Participants ( = 64), diagnosed as bipolar disorder as per the diagnostic and statistical manual of mental disorders (DSM-5), were randomly assigned to receive tDCS. Hamilton Depression Rating Scale (HDRS-17) scores were measured at the baseline, week 2, 4, and 6, and home-based tDCS (for 30 min with 2 mA) was self-administered daily.
Of the 64 patients (15.6% bipolar disorder I, 84.4% bipolar disorder II), 41 patients completed the entire assessment. In the intention-to-treat analysis, time-group interaction for the HDRS-17 [ = 2.060; = 0.108] and adverse effect differences between two groups were not statistically significant, except the pain score, which was higher in the active group than the sham group (week 0-2: < 0.01, week 2-4: < 0.05, and week 4-6: < 0.01).
Even though we found no evidence for the efficacy of home-based tDCS for patients with BD, this tool was found to be a safe and tolerable treatment modality for BD.
[https://clinicaltrials.gov/show/NCT03974815], identifier [NCT03974815].
尽管经颅直流电刺激（tDCS）已知是一种用于单相抑郁症的有前景的治疗方式，但tDCS用于双相抑郁发作（BD）的疗效和安全性仍不清楚，且基于家庭的tDCS治疗的临床试验很少。因此，我们着手研究基于家庭的tDCS治疗BD的疗效和安全性。
根据《精神障碍诊断与统计手册》（DSM-5）诊断为双相情感障碍的参与者（n = 64）被随机分配接受tDCS。在基线、第2周、第4周和第6周测量汉密尔顿抑郁量表（HDRS-17）评分，并且每天自行进行基于家庭的tDCS（2 mA，持续30分钟）。
在64例患者中（双相I型障碍占15.6%，双相II型障碍占84.4%），41例患者完成了整个评估。在意向性分析中，HDRS-17的时间-组交互作用[F = 2.060；P = 0.108]以及两组之间的不良反应差异无统计学意义，但主动治疗组的疼痛评分高于假刺激组（第0 - 2周：P < 0.01，第2 - 4周：P < 0.05，第4 - 6周：P < 0.01）。
尽管我们没有发现基于家庭的tDCS对BD患者有效的证据，但该方法被发现是一种对BD安全且可耐受的治疗方式。
[https://clinicaltrials.gov/show/NCT03974815]，标识符[NCT03974815]。
