Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)
研究概览
简要总结
The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.
详细描述
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.
Using anodal & cathodal tDCS the investigators aimed to treat auditory hallucinations, a symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 60 patients (30 in each group). 30 patients will be included in a French center (Hospital le Vinatier, sponsor of the study) and 30 in Tunisia (laboratory "vulnerability to psychosis" (Pr Gaha) à Monastir).
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
- •Schizophrenia according to Diagnostic and Statistical Manual - DSM-IV
- •Auditory verbal hallucinations for at least 6 weeks (despite antipsychotic drugs)
- •Medication Resistance according to Kane et al., 1988
- •Age between 18 and 50 years old
- •Informed consent
排除标准
- •Concomitant major and unstable medical or neurologic illness
结局指标
主要结局
Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)
时间窗: before, after 1 week of treatment and 2 times follow up (1 & 3 months)
次要结局
- Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI(3 times: before treatment, immediately after treatment and a last evaluation 1 month after)