A Double Blind Sham Controlled Trial of tDCS for Treatment of Negative Symptoms in Patients With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Scale for the Assessment of Negative Symptoms
研究概览
简要总结
The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Schizophrenia with prominent negative symptoms
排除标准
- •other psychiatric or neurological diseases
- •specific tDCS limitations
研究组 & 干预措施
active tDCS
Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.
干预措施: transcranial direct current stimulation (Device)
Sham tDCS
Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a sham stimulation during 20 minutes. Initial stimulation followed by turning off the device as to ensure blinding.
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Scale for the Assessment of Negative Symptoms
时间窗: up to 3 months after intervention
次要结局
未报告次要终点