Efficacy of Transcranial Electrical Stimulation (tES) of Dorsolateral- Prefrontal Cortex on Emotion Processing: A Randomized, Single-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The change of event-related potentials (ERPs) before and after stimulation.
研究概览
简要总结
The aim of this study is to assess the efficacy of transcranial Electrical Stimulation (tES) on emotion processing of healthy participants. Meanwhile, the investigators evaluate the effect of tES on electroencephalography (EEG) of both resting and task-related signal. The hypothesis of this study is that tES can improve the cognitive function of emotion by modulating brain activity.
详细描述
This is a randomized, single-blind, sham-controlled study using transcranial Electrical Stimulation (tES) for 7-day treatment. Participants were randomly assigned to transcranial alternating current stimulation (tACS) group, transcranial direct current stimulation (tDCS) group or sham-control group. Active tES comprised 20 min sessions of 1.5 mA peak-to-peak current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days. Sham group was administered similarly, but with current turned off after 30s. Apart from studying the effects of tES on physiology signals, subjective scale assessments and behavioral data are performed before and after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 35 years
- •with normal or corrected to normal vision
- •participant or guardian need to sign informed consent
排除标准
- •reported neurological or psychiatric disorders
- •history of any form of transcranial electrical stimulation experience
- •use of mood stabilizer
- •history of substance abuse or dependence
- •severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma
- •use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
- •use of immunosuppressive medication such as oral steroid hormones women in pregnancy or lactation period
结局指标
主要结局
The change of event-related potentials (ERPs) before and after stimulation.
时间窗: Day1, Day7
The aim is to explore whether tES have a regulation effect on emotion processing of dynamic course. In the task, participants need to concentrate on the emotional picture with positive, negative and neutral faces. Then, different ERP components elicited by positive, negative and neutral faces using the signals recorded during facial emotion identification task. The investigators will analyze the ERP components change before and after stimulation to access tES effect on emotion processing.
The change of resting EEG power and lateralization index before and after stimulation.
时间窗: Day1, Day7
The aim is to explore whether tES have a regulation effect at-risk of frequency domain. In the resting task, 8 mins resting EEG will be recorded. During recording, participants need to remain still and relaxed with their eyes open (O) and closed (C) in two alternating orders. In order to access tES effect on resting EEG, spectral analysis will be executed after the experiment. Analysis in frequency domain also contributed to expound the brain mechanism related cerebral cortex in emotion processing. In specific, EEG power of delta, theta, alpha, beta and gamma band would be calculated after recording. Besides, the EEG lateralization index also be analyzed between left and right brain.
次要结局
- The change of scores in subjective scale measurement of Difficulties in Emotion Regulation Scale (DERS) from pre- to post-stimulation.(Day1, Day7)
- Adverse events from baseline to Day1.(Day2, Day3, Day4, Day5, Day6, Day7)
- The change of scores in subjective scale measurement of State-Trait Anxiety Inventory from pre- to post-stimulation.(Day1, Day7)
- The change of behavioral data from pre- to post-stimulation.(Day1, Day7)