Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: A randomized controlled trial

Hong Xing Wang*, Kun Wang, Wen Rui Zhang, Wen Feng Zhao, Xiao Tong Yang, Li Wang, Mao Peng, Zhi Chao Sun, Qing Xue, Yu Jia, Ning Li, Kai Dong, Qian Zhang, Shu Qin Zhan, Bao Quan Min, Chun Qiu Fan, Ai Hong Zhou, Hai Qing Song, Lu Yin, Tian Mei SiJing Huang, Jie Lu, Hai Xia Leng, Wei Jun Ding, Yuan Liu, Tian Yi Yan, Yu Ping Wang

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

Background:Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD). The study is to evaluate the efficacy and safety of tACS treating MDD.Methods:This is an 8-week, double-blind, randomized, placebo-controlled study. Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), following a 4-week observation period (week 8). The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8. Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17, the proportion of participants having improvement in the clinical global impression-improvement, the change in HDRS-17 score (range, 0-52, with higher scores indicating more depression) over the study, and variations of brain imaging and neurocognition from baseline to week 4. Safety will be assessed by vital signs at weeks 4 and 8, and adverse events will be collected during the entire study.Discussion:The tACS applied in this trial may have treatment effects on MDD with minimal side effects.Trial registration:Chinese Clinical Trial Registry, ChiCTR1800016479; http://www.chictr.org.cn/showproj.aspx?proj=22048.

Original languageEnglish
Pages (from-to)61-67
Number of pages7
JournalChinese Medical Journal
Volume133
Issue number1
DOIs
Publication statusPublished - 5 Jan 2020

Keywords

  • Major depressive disorder
  • Transcranial alternating current stimulation
  • Treatment
  • Trial

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