Treatment of auditory hallucinations in schizophrenia with bilateral theta burst stimulation - renewal proposal.

听觉言语幻觉（AH）是精神分裂症的一个主要症状，严重折磨人，并增加暴力和自杀的风险。他们的感知能力与大脑中与语言相关的颞顶叶区域的活动增加有关。在高达25%-30%的患者中，AH抵抗治疗努力。重复经颅磁刺激（rTMS）可以减少局灶性脑亢进，并应用于左颞顶叶皮层，已被证明可以改善AH。然而，对照多中心临床试验仍然缺失，效应量适中，治疗耗时。通过持续的θ波爆发刺激（cTBS），一种高级形式的rTMS具有短暂的刺激会话，可以更快、更有效地调节皮质亢进和相关的AH。通过这项多中心、假对照临床试验，我们旨在为cTBS治疗精神分裂症患者AH的有效性和安全性提供证据。参与的患者（n=64）接受为期三周的每日（5次/周）cTBS或左、右颞顶皮层假治疗（每天1200次脉冲）。假刺激将采用主动假线圈，允许双盲治疗。治疗结束时，将通过psyrat -AH量表比较两组对AH的疗效。次要终点是精神病症状严重程度（PANSS）、整体功能（GAF）和临床整体印象（CGI）。治疗后1、3和6个月的随访评估将调查治疗效果的稳定性。

Auditory verbal hallucinations (AH), a cardinal symptom of schizophrenia, are severely distressing and increase the risk for violence and suicide. Their perception is associated with increased activity in speech-related temporoparietal areas of the brain. In up to 25%-30% of patients, AH resist therapeutic efforts. Repetitive transcranial magnetic stimulation (rTMS) can reduce focal brain hyperactivity and, applied to the left temporoparietal cortex, has been shown to ameliorate AH. However, controlled multicentre clinical trials are still missing, effect sizes are moderate, and the treatment is time-consuming. With continuous theta burst stimulation (cTBS), an advanced form of rTMS with brief stimulation sessions is available for a quicker and potentially more effective modulation of cortical hyperactivity and associated AH. With this multicentre, sham-controlled clinical trial, we aim at providing evidence for the efficacy and safety of cTBS in the treatment of AH in patients with schizophrenia. Participating patients (n=64) receive a three weeks course of daily (5/week) cTBS or sham treatment to the left and right temporoparietal cortex (1200 impulses daily). Sham stimulation will be applied by an active sham-coil that allows for a double-blind treatment. Efficacy on AH will be compared between both groups by the PSYRATS-AH subscale at the end of treatment. Secondary endpoints are psychotic symptom severity (PANSS), global functioning (GAF), and clinical global impression (CGI). Follow-up assessments 1, 3 and 6 months after treatment will investigate the stability of treatment effects.