rTMS Add on Value for Amelioration of Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Scale for the Assessement of Negative Symptoms (SANS)
研究概览
简要总结
Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.
详细描述
In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated. The active study arms are high-frequency rTMS and iTBS of the left dorsolateral prefrontal cortex to treat negative symptoms in schizophrenia. The control arm will include the same number of patients as each active arm and includes both sham rTMS and sham iTBS in the same proportion as the active treatments.
Standards of the trial will be harmonized across four clinical centers with the aim to pool data for analysis. Each center is responsible for ethical approval and adherence to good clinical practice by itself (Sponsor).
Interim analysis: Several meta-analyses of the effect of rTMS/iTBS on negative symptoms in schizophrenia showing heterogeneous effect sizes have been published since begin of the trial. Thefore, an interim analysis after inclusion of at least 15 patients in each arm was added to the protocol. In case of null findings and low effect sizes (no differences of either rTMS or TBS vs. sham in the primary outcome), the trial will be terminated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-10: schizophrenia with primarily negative symptoms
- •Age: 18-75 years
- •at least 35 Points at the composite score of the SANS
- •stabe medication during the last 2 weeks (at the investigator's discretion)
- •written informed consent (by the patient or guardian)
排除标准
- •clinically relevant unstable concomitant somatic diseases
- •previous treatment by rTMS
- •conditions in which TMS may not be applicated, as e.g., cardiac pacemakers or ferromagnetic implants
- •history of epileptic seizures
- •current substance or alcohol abuse, or clinically relevant comorbidity (according to M.I.N.I. interview)
- •unacceptable concomitant medication (benzodiazepines in higher doses, e.g., Lorazepam > 2 mg/d, Diazepam > 10 mg/d)
- •insufficient knowledge of the language of the country of the treatment site
- •pregnancy and nursing period
- •current statutory hospitalisation
研究组 & 干预措施
high-frequency repetitive transcranial magnetic stimulation
repetitive transcranial magnetic stimulation over left dorsolateral prefrontal cortex using 3000 pulses applied with 10Hz and 120% resting motor threshold
干预措施: high-frequency rTMS (Device)
theta burst stimulation
intermittent theta burst stimulation over left dorsolateral prefrontal cortex using 600 pulses applied in trains of 10 triplets/bursts (50Hz) with 8s intertrain-interval and 120% resting motor threshold
干预措施: TBS (Device)
sham rTMS
half of the patients with high-frequency repetitive transcranial magnetic stimulation and half of the patients with theta burst Stimulation with angled coil (45 degree) or sham coil
干预措施: placebo (Device)
结局指标
主要结局
Scale for the Assessement of Negative Symptoms (SANS)
时间窗: 4 weeks
negative symptoms in schizophrenia with 25 items and a range 0-125 with higher score representing more symptoms
次要结局
- Memory span test (digit span)(4 weeks, 12 weeks)
- cigarettes(4 weeks, 12 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(2 weeks, 4 weeks, 12 weeks)
- Resting state electroencephalogram (EEG)(4 weeks)
- Positive and Negative syndrome scale (PANSS)(2 weeks, 4 weeks, 12 weeks)
- test of attention (d2)(4 weeks, 12 weeks)
- Major Depression Inventory (MDI)(2 weeks, 4 weeks, 12 weeks)
- Hamilton depression rating scale (HDRS)(2 weeks, 4 weeks, 12 weeks)
- Scale for the Assessement of Negative Symptoms (SANS)(2 weeks, 4 weeks, 12 weeks)
- Clinical global impression (CGI)(2 weeks, 4 weeks, 12 weeks)
- magnetic resonance imaging (MRI)(4 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Clinical Professor
University of Regensburg