Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
The goal of this project is to train currently major depressed patients on fundamental aspects of working memory while the investigators administer transcranial Direct Current Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training sessions. This working memory training would be performed using adaptive Paced Auditory Serial Addition Tasks (PASAT). The effects after two weeks of working memory training combined with tDCS or sham placebo (10 sessions) will be measured on different variables, each measured at the start and at the end of the two weeks of training. The investigators expect the greatest anti depressant results and cognitive enhancements in the group of depressed patients that received tDCS combined with working memory training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Depressive Disorder, Major (SCID)
- •HDRS-24 > 21
排除标准
- •Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.
- •Any axis II disorders.
- •Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
- •Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.
研究组 & 干预措施
active tDCS and working memory training
干预措施: active tDCS and working memory training (Other)
sham tDCS and working memory training
干预措施: sham tDCS and working memory training (Other)
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 4 weeks
The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.
次要结局
- Salivary Cortisol(2 weeks)
- Working memory task in combination with pupil dilatation(2 weeks)
- Heart Rate Variability(2 weeks)
- Beck Depression Inventory(4 weeks)
- follow-up measure(after two weeks)
- Internal Shift Task(2 weeks)
研究者
Andre Brunoni
Research Associate
University of Sao Paulo