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Efficacy of repetitive transcranial magnetic stimulation for the treatment of negative symptoms in schizophrenia

重复经颅磁刺激治疗精神分裂症阴性症状的疗效

基本信息

批准号：
34060750
负责人：
Professor Dr. Peter Falkai
金额：
--
依托单位：
Klinik für Psychiatrie und Psychotherapie
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2007
资助国家：
德国
起止时间：
2006-12-31 至 2013-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/34060750?language=en
关键词：
Efficacy repetitive transcranial magnetic stimulation

项目摘要

Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials. However, the data on efficacy remain inconclusive. Controlled trials with larger sample sizes and longer treatment periods are required to reach level I evidence of efficacy (according to evidence based medicine criteria). The suggested study is a randomized, parallel-group, rater- and patients-blind design trial and compares real and placebo rTMS in 126 schizophrenic patients suffering from predominantly negative symptoms. All patients receive either real or placebo (sham-) rTMS as add-on treatment over a period of 3 weeks and will be assessed during a follow-up period of further 12 weeks. The results of the study will allow to answer the question whether rTMS is an effective evidence-based add-on intervention in the negative symptoms in schizophrenia, this treatment technique will be a therapeutic option to change the unfavourable course of schizophrenia and needs to be established in clinical practice.

精神分裂症是一种主要的精神障碍，给患者及其亲属带来了巨大的负担。尽管接受了第二代抗精神病药物的治疗，但阴性症状和认知障碍往往持续存在，并决定了不利的过程，包括生活质量下降。前额叶重复经颅磁刺激(RTMS)是一种有前途的非侵入性生物学技术，在大多数小型安慰剂对照试验中，辅助应用于正在进行的抗精神病药物治疗被证明是安全的，并与阴性症状的改善有关。然而，关于疗效的数据仍然没有定论。样本量较大、疗程较长的对照试验需要达到I级疗效证据(根据循证医学标准)。这项建议的研究是一项随机、平行组、评价者和患者盲设计试验，比较了126名以阴性症状为主的精神分裂症患者的真实rTMS和安慰剂rTMS。所有患者都接受真实或安慰剂(假)rTMS作为附加治疗，为期3周，并将在接下来的12周内进行评估。这项研究的结果将回答rTMS是否是一种有效的循证辅助干预精神分裂症阴性症状的问题，这一治疗技术将是改变精神分裂症不利病程的一种治疗选择，需要在临床实践中建立。