NCT01373866已完成不适用
Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial
University Hospital, Lille4 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2010年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Severity and Frequency of Hallucinations
研究概览
简要总结
- The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)
- This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations
- The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right-handed Female/Male, [13-60 y.o.],
- •Schizophrenia (DSM-IV-TR diagnosis),
- •Drug-resistant hallucinations (Kinon & Kane criteria, 1993),
- •Unmodified antipsychotic dosage during the 30 days preceding rMTS,
- •No anticonvulsive medication,
- •No neurological disorder, no addictive behavior,
- •Matched for sex, age and PANSS scores,
- •Consent to participate to the study,
排除标准
- •Pregnancy
- •Contraindication to MRI scan
- •Contraindication to rTMS treatment
- •Claustrophobia
- •No social insurance
结局指标
主要结局
Severity and Frequency of Hallucinations
时间窗: Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)
Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)
次要结局
- MRI changes(Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1))
- Clinical State(Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12))
研究者
研究点 (4)
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