Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Auditory Hallucinations
- 发起方
- University Hospital Tuebingen
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
- 状态
- 已完成
- 最后更新
- 12年前
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.
研究者
Christian Plewnia, MD
Principal Investigator
University Hospital Tuebingen
入排标准
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
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)