Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study
Repetitive transcranial magnetic stimulation for the treatment of negative symptoms in residual schizophrenia: rationale and design of a sham-controlled, randomized multicenter study
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DOI：
10.1007/s00406-009-0060-y
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发表时间：
2009-11-01
影响因子：
4.7
通讯作者：
Wobrock, T.
中科院分区：
文献类型：
--
作者：
Cordes, Joachim;Falkai, P.;Wobrock, T.
目前的荟萃分析显示，重复经颅磁刺激(RTMS)对精神分裂症患者阴性症状的影响很小，但意义重大。需要进一步的对照多中心试验，在更大的患者样本中评估rTMS对精神分裂症阴性症状的临床疗效。这项多中心、随机、假对照、评价者和患者盲的临床试验的目的是观察在抗精神病药物治疗的基础上加用3周10赫兹高频rTMS治疗精神分裂症的疗效，并在12周的随访中评价其疗效。主要疗效终点是阴性症状的减少，通过阳性和阴性症状评分的阴性总和(PANSS)来评估。每组中63的样本大小将具有80%的能力来检测0.50的效果大小。数据分析将基于治疗人群的意向。这项研究将在德国的三所大学医院进行。这项研究将为rTMS治疗阴性症状的疗效提供信息。除了精神病理学，还将评估其他结果指标，如神经认知、社会功能、生活质量和神经生物学参数，以探讨精神分裂症患者rTMS的基本机制。该试验的主要局限性是抗精神病药物剂量变化的潜在影响，以及确保充分失明的困难。
Current meta-analysis revealed small, but significant effects of repetitive transcranial magnetic stimulation (rTMS) on negative symptoms in patients with schizophrenia. There is a need for further controlled, multicenter trials to assess the clinical efficacy of rTMS on negative symptoms in schizophrenia in a larger sample of patients. The objective of this multicenter, randomized, sham-controlled, rater- and patient-blind clinical trial is to investigate the efficacy of 3-week 10-Hz high frequency rTMS add on to antipsychotic therapy, 15 sessions per 3 weeks, 1,000 stimuli per session, stimulation intensity 110% of the individual motor threshold) of the left dorsolateral prefrontal cortex for treating negative symptoms in schizophrenia, and to evaluate the effect during a 12 weeks of follow-up. The primary efficacy endpoint is a reduction of negative symptoms as assessed by the negative sum score of the positive and negative symptom score (PANSS). A sample size of 63 in each group will have 80% power to detect an effect size of 0.50. Data analysis will be based on the intention to treat population. The study will be conducted at three university hospitals in Germany. This study will provide information about the efficacy of rTMS in the treatment of negative symptoms. In addition to psychopathology, other outcome measures such as neurocognition, social functioning, quality of life and neurobiological parameters will be assessed to investigate basic mechanisms of rTMS in schizophrenia. Main limitations of the trial are the potential influence of antipsychotic dosage changes and the difficulty to ensure adequate blinding.