A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Positive and negative syndrome scale ( PANSS )
研究概览
简要总结
The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients male and female with the range of 18-50 years of age
- •The diagnosis of schizophrenia according to DSM-IV-TR
- •Completion of consent form
- •Being under supervision of a psychiatrist,
- •Being able to adhere to treatment schedule,
- •Having stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for psychotropic agents prior to entering the Study
排除标准
- •The history of rTMS treatment for any reason
- •Cardiac pacemaker
- •Acute heart attack
- •The risk of seizure with any reasons
- •The history of epilepsy or seizure in the first relatives
- •Any metal in head
- •Brain trauma
- •Breastfeeding
- •Drug dependency
结局指标
主要结局
Positive and negative syndrome scale ( PANSS )
时间窗: Change of baseline in negative symptoms at 20 sessions
次要结局
- Calgary depression for schizophrenia scale (CDSS)(3 times (Before treatment, session 10, immediately after treatment))
- Schizophrenia quality of life scale (SQLS)(3 times (Before treatment, session 10, immediately after treatment))
- Cantab Schizophrenia Battery(3 times (Before treatment, session 10, immediately after treatment))
- QEEG and low resolution brain electromagnetic tomography (LORETA)(3 times (Before treatment,session 10, immediately after treatment))
研究者
reza kazemi
Researcher
University of Tehran