【ChiCTR1900025550】Concurrent Transcranial Direct Current Stimulation with Cognitive Training for Cognitive Functions of Schizophrenia Patients

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基本信息

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ChiCTR1900025550

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2019-08-31

临床申请受理号

靶点

适应症

精神分裂症

试验通俗题目

Concurrent Transcranial Direct Current Stimulation with Cognitive Training for Cognitive Functions of Schizophrenia Patients

试验专业题目

A Randomised Controlled Trial of Online Transcranial Direct Current Stimulation (tDCS) in Enhancing the Effects of Cognitive Training in patients with Schizophrenia

申办单位信息

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临床试验信息

试验目的

The primary objective of the study is to investigate the adjunct effect of online tDCS with cognitive training on specific cognitive domains in stable schizophrenia patients. (i) right after the intervention (ii) whether maintenance effect at 1 month after intervention. The secondary objective of the study is to probe (i) any effects on affective , psychotic and negative symptoms; (ii) psychosocial functioning, subjective quality of life (QOL); (iii) the motivation and enjoyment of continuing playing the computerized cognitive training; (iv) the tolerability and adverse events of tDCS among patients with schizophrenia.

试验分类

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试验类型

随机平行对照

试验分期

治疗新技术

随机化

The subjects will be randomly allocated to the intervention group or the control group by a block randomization procedure (1:1 allocation) . The randomization sequence will be generated by an online randomization tool (www.sealedenvelop.com) .

盲法

Double Blind

试验项目经费来源

N/A

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-08-01

试验终止时间

2020-06-30

是否属于一致性

入选标准

1. Patients receiving rehabilitation service in Tai Po Hospital aged between 18-65 years old; 2. diagnosis of schizophrenia meeting the diagnostic criteria of the World Health Organizations 10thversion of the International Statistical Classification of Disease and Related Health Problems (ICD-10),it will be made clinically by the study psychiatrist based on ICD-10; 3. right-handedness; 4. able to understand spoken instructions in Cantonese and able to read traditional Chinese.；

排除标准

1. History of significant head trauma; 2. active abuse of alcohol or illegal substances; 3. significant neurologic history such as dementia, stroke, seizure, Parkinsons disease, multiple sclerosis; 4. concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors ; 5. documented history of learning disability; f. implanted with pacemakers, intracranial electrodes, defibrillators; g. changes in medication regime over the 2 weeks before or during the study period.；

研究者信息

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试验机构

香港中文大學大埔醫院

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