Efficacy of Transcranial Direct Current Stimulation (tDCS) in Symptoms, Quality of Life, Cognitive Deficits and Brain Physiology of Patients With Obsessive-compulsive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Beck Anxiety Questionnaire (BAI)
研究概览
简要总结
This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (OCD) that are randomized in 3 experimental groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Obsessive-compulsive Disorder by a psychiatrist and DSM-5-based behavioral checklist
- •being 18-50 years old
- •providing written informed consent
- •If female, negative urine pregnancy test
- •stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
排除标准
- •pregnancy
- •alcohol or substance dependence
- •history of seizure
- •history of neurological disorder
- •history of head injury
- •presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
研究组 & 干预措施
Control group
In the placebo group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of sham electrical stimulation on 5 consecutive days with two sessions per day.
干预措施: transcranial direct current stimulation (Device)
tDCS group 1
In the first experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 1 mA electrical stimulation on 5 consecutive days with two sessions per day.
干预措施: transcranial direct current stimulation (Device)
tDCS group 2
In the second experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 2 mA electrical stimulation on 5 consecutive days with two sessions per day.
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Beck Anxiety Questionnaire (BAI)
时间窗: up to 1 month after the intervention
Score in the Beck Anxiety Questionnaire (BAI). The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale
时间窗: up to 1 month after the intervention
Score in the Yale-Brown Obsessive-Compulsive (Y-BOCS). Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms.
Response inhibition task 1
时间窗: up to 1 month after the intervention
Performance in the response inhibition tasks (Flanker test)
Working memory task
时间窗: up to 1 month after the intervention
Performance in the working memory task as an executive function task
Response inhibition task 2
时间窗: up to 1 month after the intervention
Performance in the response inhibition tasks (Go/No-Go task)
次要结局
- Beck Depression Questionnaire (BDI-II)(up to 1 month after the intervention)
- electroencephalogram (EEG) oscillatory power(up to 1 month after the intervention)
- electroencephalogram (EEG) functional connectivity(up to 1 month after the intervention)
- Quality of Life Questionnaire (WHOQUL)(up to 1 month after the intervention)
研究者
Mohammad Ali Salehinejad
Principal Investigator
Technical University of Dortmund