【ChiCTR2200056203】Effect of Transcranial Direct Current Stimulation (tDCS) on Improving Inhibitory Control and Working Memory in Children with Attention-Deficit / Hyperactivity Disorder (ADHD) and comorbid Autism Spectrum Disorder (ASD) – A Randomised Controlled Trialutism Spectrum Disorder (ASD) – A Randomised Controlled Trial

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基本信息

登记号

ChiCTR2200056203

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

2022-02-01

临床申请受理号

靶点

适应症

多动症(ADHD)和自闭症(ASD)

试验通俗题目

Effect of Transcranial Direct Current Stimulation (tDCS) on Improving Inhibitory Control and Working Memory in Children with Attention-Deficit / Hyperactivity Disorder (ADHD) and comorbid Autism Spectrum Disorder (ASD) – A Randomised Controlled Trialutism Spectrum Disorder (ASD) – A Randomised Controlled Trial

试验专业题目

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临床试验信息

试验目的

The primary objective of the study is to evaluate the effect of tDCS on inhibitory control and working memory in primary school-aged children with ADHD and comorbid ASD immediately after the intervention and 1-week post-intervention. The secondary objectives of the study include: 1. To compare the effect of tDCS on clinical symptoms of ADHD and ASD between the intervention group and control group at 1 week post-intervention. 2. To evaluate the safety profile of tDCS and describe any adverse events of tDCS in children with ADHD and comorbid ASD.

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试验类型

随机平行对照

试验分期

其它

随机化

The subjects will be randomly allocated to the intervention group or the control group by a block randomization procedure with 1:1 group allocation. Allocation concealment will be adopted to prevent selection bias. The randomization sequence will be electronically generated.

盲法

Not stated

试验项目经费来源

The Chinese University of Hong Kong

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-11-29

试验终止时间

2022-06-30

是否属于一致性

入选标准

1. Age of 6 - 12 years old; 2. Right-handed； 3. With a diagnosis of ADHD and comorbid ASD made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) by a Psychiatry specialist; 4. Able to understand spoken instructions in Cantonese and read written traditional Chinese; 5. Studying in mainstream school; 6. Currently not taking stimulant medications (Methylphenidate or Lisdexamfetamine), or agree to stop stimulant medications starting from 72 hours before the first stimulation and until one week after the last stimulation.；

排除标准

1. History of significant head trauma or skull defects; 2. Implanted with pacemakers, intracranial electrodes, defibrillators, or other metallic implants; 3. Neurological conditions including but not limited to seizure, stroke, intracranial tumors or aneurysms; 4. Sensory or motor impairments; 5. Documented history of Intellectual Disability; 6. Currently on psychotropics other than stimulants or other CNS drugs；

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nil

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