一项评估经颅磁刺激（TMS）附加疗法改善精神分裂症阴性症状价值的试验（RADOVAN）的原理与研究设计
Rationale and study design of a trial to assess TMS addon alue for the amelioration of negative symptoms of schizophrenia (RADOVAN).
作者信息
Hebel T, Langguth B, Schecklmann M, Schoisswohl S, Staudinger S, Schiller A, Ustohal L, Sverak T, Horky M, Kasparek T, Skront T, Hyza M, Poeppl T B, Riester M L, Schwemmer L, Zimmermann S, Sakreida K
机构信息
Department of Psychiatry and Psychotherapy, Regensburg University Hospital, Universitätsstraße 84, 93053, Regensburg, Germany.
Department of Psychiatry, Masaryk University and University Hospital Brno, Jihlavska 20, 625 00, Brno, Czech Republic.
出版信息
Contemp Clin Trials Commun. 2022 Jan 20;26:100891. doi: 10.1016/j.conctc.2022.100891. eCollection 2022 Apr.
BACKGROUND
Schizophrenia is a severe and often difficult to treat psychiatric illness. In many patients, negative symptoms dominate the clinical picture. Meta-analysis has suggested moderate, but significant effects of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) on these symptoms. For treatment of depression a much shorter protocol - intermittent theta burst stimulation (iTBS) - has shown to be non-inferior to conventional high-frequency rTMS. This randomized, sham-controlled, rater-blinded clinical trial assesses the effects of conventional HF-rTMS as well as of iTBS of the left dorsolateral prefrontal cortex in comparison with sham.
METHODS
The study will be conducted at two psychiatric university hospitals in Germany and at two in the Czech Republic. Assuming an effect size of 0.64 to be detected with a power of 80%, the calculated sample size is 90 patients. Primary outcome will be the difference in the Scale for the Assessment of Negative Symptoms (SANS) score between each active arm and the sham arm at end of treatment.In addition, the trial investigates effects on depressive symptoms, cognitive performance and cigarette smoking. Recording magnetic resonance imaging (MRI) and electroencephalography (EEG) data will serve to assess whether treatment success can be predicted by neural markers and is related to specific neurobiological changes.
DISCUSSION
This is a clinical trial directly comparing 10 Hz-rTMS and iTBS in a sham-controlled manner in treating negative symptoms of schizophrenia. If successful, this would present an interesting treatment option for a chronic and severe condition that can be applied at most psychiatric hospitals and only takes up a few minutes per day.
TRIAL REGISTRATION NUMBER
This trial has been registered at clinicaltrials.gov, Identifier: NCT04318977.
DATA DISSEMINATION
Results from the trial shall be published in peer-reviewed journals and presented at meetings and conferences.
背景
精神分裂症是一种严重且通常难以治疗的精神疾病。在许多患者中，阴性症状主导临床表现。荟萃分析表明，高频重复经颅磁刺激（HF-rTMS）对这些症状有中等但显著的效果。对于抑郁症的治疗，一种更短的方案——间歇性theta爆发刺激（iTBS）——已被证明不劣于传统的高频rTMS。这项随机、假对照、评估者盲法的临床试验评估了传统HF-rTMS以及左侧背外侧前额叶皮质的iTBS与假刺激相比的效果。
方法
该研究将在德国的两家精神科大学医院和捷克共和国的两家医院进行。假设检测到的效应大小为0.64，检验效能为80%，计算得出的样本量为90名患者。主要结局将是各治疗组与假刺激组在治疗结束时阴性症状评估量表（SANS）评分的差异。此外，该试验还研究了对抑郁症状、认知表现和吸烟的影响。记录磁共振成像（MRI）和脑电图（EEG）数据将用于评估治疗成功是否可以通过神经标志物预测以及是否与特定的神经生物学变化相关。
讨论
这是一项以假刺激为对照直接比较10Hz-rTMS和iTBS治疗精神分裂症阴性症状的临床试验。如果成功，这将为一种慢性重症疾病提供一个有趣的治疗选择，该方法可在大多数精神科医院应用，且每天只需几分钟。
试验注册号
该试验已在clinicaltrials.gov注册，标识符：NCT04318977。
数据传播
试验结果将在同行评审期刊上发表，并在会议上展示。
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