Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Scale for the Assessment of Negative Symptoms (SANS)
研究概览
简要总结
The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.
详细描述
This study will evaluate whether the intermittent Theta Burst Stimulation (iTBS), a new high frequency TMS protocol is efficient in the treatment of the Negative Symptoms of schizophrenia.
Neuroimaging studies demonstrate that hypoactivity in the left dorsolateral prefrontal cortex (LDLPFC) was associated with negative symptoms.
The investigators hypothesize that iTBS applied to LDLPFC will improve negative symptoms and will improve activity of the LDLPFC measured with Magnetic Resonance Spectroscopy (MRS).
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 DSM-IV
- •Negative symptoms for at least 6 weeks
- •Medication resistance according to Kane et al., 1988
- •Age between 18 and 50 years old
- •Informed consent
排除标准
- •Contraindication to TMS
- •Pregnancy
结局指标
主要结局
Scale for the Assessment of Negative Symptoms (SANS)
时间窗: before, after 2 weeks of treatment, and 3 times follow-up (1, 3 and 6 months)
次要结局
- Neurochemical impact of treatment measured by 1H-MRS, DTI and resting MRI(3 times, before treatment, immediatly after treatment and a last evaluation 3 months after)
研究者
Dr. E. Poulet
PUPH
Hôpital le Vinatier