A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Repeatable Battery for the Assessment of Neuropsychological Status for cognition
研究概览
简要总结
A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for cognitive impairments in 120 chronic schizophrenia patients
详细描述
OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the treatment of cognitive impairments in 120 chronic patients with schizophrenia.
METHODS:
- Clinical Trial: The study consists of 8 weeks of treatment.
- Assessment Procedures:
2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks.
2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists, which is comprised of a total score and 5 age-adjusted index scores for attention, language, delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese version of RBANS has been evaluated for the test-retest reliability and clinical validity between schizophrenia patients and control subjects. Cognitive performance was measured at baseline and at 8-weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizopherenia by two senior psychiatrists
- •Right-handed
- •Between 18 and 60 years and Han Chinese
- •Duration of symptoms at least 60 months
- •Received stable doses of antipsychotic drugs at least 12 months
- •With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS < 24)
排除标准
- •A DSM-IV Axis I diagnosis other than schizophrenia
- •Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
- •Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
- •Severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
- •Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
- •Education level less than 5 years by subject report,
- •Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
- •Subjects who suffered from alcohol or illegal drug abuse/dependence
研究组 & 干预措施
10 Hz treatment group
In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
干预措施: 10 Hz treatment group (Device)
20 Hz treatment group
In active rTMS, 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
干预措施: 20 Hz treatment group (Device)
Control Group
In sham rTMS, all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
干预措施: Control Group (Device)
结局指标
主要结局
Repeatable Battery for the Assessment of Neuropsychological Status for cognition
时间窗: 8 weeks
cognitive performance
Positive and Negative Syndrome Scale for clinical symptoms
时间窗: 8 weeks
clinical symptoms
次要结局
- Treatment Emergent Symptoms Scale for side effects(8 weeks)
研究者
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital