The Effect of Transcranial Direct Current Stimulation (tDCS) on Cognitive Control and Emotion Regulation in Depressed Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change of positive and negative affect
研究概览
简要总结
Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies (ERS) are both central characteristics of major depression. Both are associated with reduced activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. The goal of this randomized, sham-controlled, double blind clinical trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC and ERS in depressed patients compared to healthy subjects. Overall, the study will include 44 participants (22 depressed Patients and 22 healthy subjects). Each participant will complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures (heart rate variability). The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this experiment will provide new and reliable data for the development of new treatment methods.
详细描述
- Working hypothesis: anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) can enhance healthy and impaired cognitive control (CC) and reduce the use of dysfunctional emotion regulation strategies.
- Previous work of the investigators: The investigators previous work has provided decisive evidence for polarity-specific activity-dependent effects of tDCS to the left dlPFC on cognitive planning and control of emotional information processing in healthy subjects and patients with MD. Particularly, reduced prefrontal brain activity during a working memory task in patients with MD was found by using near infrared spectroscopy (NIRS). In addition, the investigators demonstrated that a single session, anodal, activity enhancing tDCS to the left dlPFC ameliorates deficient CC in patients with depression, whereas cathodal, activity reducing tDCS, induces a depression-like negativity bias in healthy subjects. Furthermore, the investigators showed that during anodal tDCS of the left dlPFC healthy subjects showed (a) better performance in a CC task (b) no increase in angry mood after the task compared to a control group and (c) that elevated angry mood was associated to a worse performance in the CC task.
- Aims and workplan: to investigate the effects of anodal tDCS of the left dLPFC in healthy and depressed subjects the investigators will conduct a double-blind, randomized, sham-controlled, cross-over design. In two sessions each participant (22 depressed and 22 healthy subjects, N= 44) will complete a CC task while receiving anodal tDCS (1 mA) to the left dlPFC in one session and sham tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •history of seizures
- •metal device throughout the body
- •pregnancy
- •use of von antipsychotics / mood stabilizer
- •diagnosed bipolar disorder
- •current substance abuse (nicotine excluded)
- •diagnosed psychotic diseases
- •diagnosed anorexia nervosa
- •diagnosed personality disorders: cluster A, antisocial personality disorder, borderline personality disorder
- •Exclusion Criteria for healthy participants:
- •history of affective disorders or current affective disorder
结局指标
主要结局
Change of positive and negative affect
时间窗: The positive and negative affect is assessed (a) right before and after the PASAT in two sessions through study completion, on average 10 days. And (b) also after the resting phase in two sessions through study completion, on average 10 days.
Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase.
Interstimulusintervall and number of correct trials in the PASAT
时间窗: Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.
To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed.
Heart rate variability
时间窗: in two sessions through study completion, on average 10 days
The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect.
Score in state rumination questionnaire
时间窗: in two sessions through study completion, on average 10 days
The state rumination will be measured after the resting phase
次要结局
未报告次要终点