Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in motor evoked potential(MEP)
研究概览
简要总结
The purpose of this study is to explore the therapeutic effect and mechanism of transcranial magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.
详细描述
The study was a parallel control design trial for 2 weeks. Patients with schizophrenia were treated with 10-Hz rTMS on left motor cortex (added to the ongoing treatment). Clinical symptoms and MEP were assessment before and after rTMS treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The diagnosis of schizophrenia according to DSM-IV；
- •At least two item of Abnormal Involuntary Movement Scale（AIMS） must be 2 points or higher
- •these symptoms are not from Parkinson，tourette's syndrome,huntington disease
- •Signed an informed consent
排除标准
- •rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
- •patients to be diagnosed according to DSM-IV for substance abused, development delayed
- •current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines
- •Acute risk of suicide and impulse
- •history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG
- •pregnant and lactant women
研究组 & 干预措施
tardive dyskinesia group
tardive dyskinesia group will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 30 stimuli each (i.e., 1800 stimuli) and an intertrain interval of 12 sec in primary motor cortex（M1）.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Healthy control group
结局指标
主要结局
Change from baseline in motor evoked potential(MEP)
时间窗: 2 times (Before treatment,immediately after treatment)
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）
时间窗: 2 times (Before treatment,immediately after treatment)
次要结局
- Change from baseline in Barnes Akathisia Rating Scale（BARS）(2 times (Before treatment,immediately after treatment))
- Change from baseline in Simpson-Angus Scale（SAS）(2 times (Before treatment,immediately after treatment))
- Change from baseline in cortical silent period(2 times (Before treatment,immediately after treatment))
- Change from baseline in clinical global impression (CGI)(2 times (Before treatment,immediately after treatment))
- Change from baseline in short interval intracortical inhibition(SICI）(2 times (Before treatment,immediately after treatment))
- Change from baseline in intracortical facilitation(ICF）(2 times (Before treatment,immediately after treatment))
- Change from baseline in Positive and Negative Syndrome Scale（PANSS）(2 times (Before treatment,immediately after treatment))