Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
研究概览
简要总结
First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •auditory hallucinations at least once a week
- •Schizophrenia (DSM-IV)
- •stable treatment setting (in- or out-patient)
- •no change of antipsychotics during and at least 1 week before treatment initiation
排除标准
- •benzodiazepines > 1,5mg lorazepam / d
- •pregnancy
- •metal parts in the brain
- •cardiac pacemaker
- •deep brain stimulation
研究组 & 干预措施
cTBS
干预措施: continuous theta burst stimulation (cTBS) (Procedure)
Sham cTBS
干预措施: sham cTBS (Procedure)
结局指标
主要结局
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
时间窗: 3 weeks
Change of PSYRATS AH score compared to baseline after 3 weeks of treatment
次要结局
- Hallucination change score (HCS)(3 and 6 weeks)
- Positive and Negative Symptom Scale (PANSS)(3 and 6 weeks)
- PSYRATS subscale for auditory hallucinations(6 weeks)
研究者
Christian Plewnia, MD
Principal Investigator
University Hospital Tuebingen