Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia: a Double-Blind, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in Positive and Negative Syndrome Scale(PANSS)
研究概览
简要总结
Based on the hypothesis that low-frequency deep transcranial magnetic stimulation(dTMS) on anterior cingulate cortex （ACC） could down-regulate the glutamate level of ACC and regulate the acc-related 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 low-frequency deep transcranial magnetic stimulation on SZ patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of ACC
详细描述
This study includes 20 treatment resistance schizophrenia patients and 20 healthy controls.This study will investigate 1)abnormalities of the glutamate level of ACC in patients with schizophrenia compared to healthy controls by using 1H-MRS technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on anterior cingulate 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 60 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 60
- •After 4 weeks of treatment with a sufficient dose of an antipsychotic (equivalent dose of 400 ~ 600 mg/ day chlorpromazine (CPZ)), no clinical improvement was achieved (at least two items in PANSS scale P1,P2,P3,N1,N4,N6,G5 and G9 ≥4 points, or cgi-s ≥4 points)
- •Right-handedness, normal hearing, visual acuity or corrected visual acuity
- •Written informed consent of the patient and his/her family
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
- •A history of MECT within 6 months,or those with contraindications to MRI,rTMS
- •Medically unstable for at least 1 month (PANSS score fluctuation>10%)
结局指标
主要结局
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
时间窗: baseline,24 hours after the dTMS treatment,30 days
Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 30 days
Change from baseline in MATRICS Consensus Cognitive Battery
时间窗: baseline,24 hours after the rTMS treatment,30 days
MATRICS Consensus Cognitive Battery
次要结局
- Change in glutamate level(baseline,24 hours after the dTMS treatment)
- Change of ACC neurogenesis(baseline,24 hours after the dTMS treatment)