Exploration of the Deep Transcranial Magnetic Stimulation for Treatment Resistant Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change from baseline in MATRICS Consensus Cognitive Battery
研究概览
简要总结
Negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. Based on the hypothesis that deep transcranial magnetic stimulation(dTMS) on prefrontal cortex #PFC# could down-regulate the glutamate level of PFC and regulate the functional network in patients with treatment resistance schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate therapeutic efficacy of high-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of PFC
详细描述
This study includes 87 treatment resistance schizophrenia patients. This study will investigate 1)abnormalities of the glutamate level of PFC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal dTMS treatment pattern on cognitive function.
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, 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
- •Patients with schizophrenia who meet the dsm-5 diagnostic criteria
- •Aged from 18 to 55
- •Right-handedness, normal hearing, visual acuity or corrected visual acuity
- •Written informed consent of the patient and his/her family
- •All patients received MINI 7.0 structured interviews
排除标准
- •Patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine
- •Current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate
- •Medically unstable for at least 1 month
结局指标
主要结局
Change from baseline in MATRICS Consensus Cognitive Battery
时间窗: baseline,24 hours after the rTMS treatment,40 days
MATRICS Consensus Cognitive Battery
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
时间窗: baseline,24 hours after the dTMS treatment,40 days
Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 40 days
次要结局
- Change of PFC neurogenesis(baseline,24 hours after the dTMS treatment,40days)