Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia
Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Concomitant major and unstable medical or neurologic illness
- Pregnant
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：active tDCS
tDCS active; - Intensity = 2 milliamps (mA) during 20 minutes. ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC combined with cathodal tDCS applied over the left temporoparietal junction (TPJ). 10 sessions, 2 per day |
Intensity 2 mA during 20 minutes, 2 times per day
其他名称：
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安慰剂比较：sham tDCS
tDCS placebo same electrode montage than in the active group.
30 sec of active tDCS in the beginning of the stimulation sessions; ramp up/ramp down 30 sec
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sham condition as delivered by the stimulator
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)
大体时间：before, after 1 week of treatment and 2 times follow up (1 & 3 months)
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before, after 1 week of treatment and 2 times follow up (1 & 3 months)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI
大体时间：3 times: before treatment, immediately after treatment and a last evaluation 1 month after
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3 times: before treatment, immediately after treatment and a last evaluation 1 month after
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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