Effects of tDCS-enhanced Cognitive Control Training on Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change of MADRS scores
研究概览
简要总结
Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation.
The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS.
As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully.
Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured.
To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors.
Sustainability of the training effects will be measured at a follow-up visit (3 months later).
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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •current Major Depressive Episode
- •right handedness
排除标准
- •history of seizures
- •Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- •pregnancy
- •use of mood stabilizers
- •diagnosed bipolar disorder
- •current substance abuse (nicotine excluded)
- •current substance addiction (nicotine excluded)
- •diagnosed psychotic diseases
- •diagnosed anorexia nervosa
- •diagnosed personality disorders: cluster A, antisocial personality disorder,
- •borderline personality disorder
研究组 & 干预措施
1mA anodal tDCS + cognitive control training
1 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
干预措施: 1mA tDCS (Other)
1mA anodal tDCS + cognitive control training
1 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
干预措施: Cognitive control training (Behavioral)
2mA tDCS + cognitive control training
2 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
干预措施: 2mA tDCS (Other)
2mA tDCS + cognitive control training
2 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
干预措施: Cognitive control training (Behavioral)
sham tDCS + cognitive control training
Sham tDCS (30 secs of tDCS) will be administered to the left dlPFC (F3) with 2mA at the beginning of a cognitive control training.
干预措施: Cognitive control training (Behavioral)
结局指标
主要结局
Change of MADRS scores
时间窗: Assessment one week before training start (week -1, day -5 on average) and in the last training session (week 4, day 26)
Change in Depressive Symptom severity will be measured with the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline session to the last stimulation session, scale range from 0 to 60 points, higher scores indicate a more severe depression
次要结局
- GAF score(Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average))
- Delta Mood ratings(Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average))
- Subjective performance ratings(Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average))
- BDI scores(Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average))
- RT in the DWM(Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average))
- Number of correct trials in the PASAT(Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average))
- Course of MADRS scores(Assessment once a week during training (week 1, 2 and 3 at day 5, 12 and 19 respectively on average) and at the follow up visits (week 5 and 17, day 31 and 110 on average))
- Number of correct trials in the DWM(Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average))
- Electroencephalography (EEG) measures(Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average))
- Prefrontal Brain activity (NIRS)(Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average))
- Prefrontal Brain activity (NIRS) as a predictor(Assessment one week before training start (week -1, day -5 on average))
- Genetic factors as predictors(Assessment one week before training start (week -1, day -5 on average))
- Electroencephalography (EEG) measures as a predictor(Assessment one week before training start (week -1, day -5 on average))