跳至主要内容
临床试验/NCT06880159
NCT06880159招募中不适用

Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Average standardised score of executive function tests

研究概览

简要总结

Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD).

Objective: (1) To assess the therapeutic effects of tDCS when combined with cognitive training for 10 consecutive weekdays on improving cognitive processing in children with ASD, relative to control group receiving sham-stimulation, and (2) to evaluate the associated neural mechanisms underlying the treatment effect of tDCS on children with ASD.

Methods: To assess the therapeutic effects of tDCS, 90 adolescents with ASD (age 6-12 years) will be randomly assigned to active- (n=45), or sham- (n=45) tDCS groups. Twenty-minute sessions of tDCS stimulation to the left dorsolateral prefrontal cortex (DLPRC) will be provided on 10 consecutive weekdays, in conjunction with cognitive training exercises. Participants with a head circumference of less than 53 cm will receive 1.0 mA of stimulation, while those with a circumference of 53 cm or greater will receive 1.5 mA. EEG, fNIRS and neuropsychological tests will be administered before, immediately after, and 2 months after the series of tDCS sessions.

Hypothesis: The investigators hypothesize that children with ASD who are randomly assigned to receive a montage of prefrontal tDCS, with cathode (inhibitory) placed over left DLPFC and anode (excitatory) over right supraorbital region) will evidence greater improvement in executive function (primary outcome) than children with ASD who are randomly assigned to receive sham-tDCS.

In addition to testing the primary clinical outcome, stated above, in planned exploratory analyses, the investigators will also examine the effects of tDCS on secondary outcome measures of cognitive function, including information processing speed, working memory, inhibitory control, and cognitive flexibility; and conduct exploratory mediation analyses to better understand the potential neurophysiological factors underlying the therapeutic effects of tDCS. This will include E/I ratio as exploratory mediator variables. As these secondary analyses are exploratory, the investigators will report them as such in presentations and published papers, and the investigators will not draw definitive conclusions from them. Rather, they will be used to better understand the potential impact of tDCS and the mechanisms underlying impact, and to inform future research.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •being 8-12 years old
  • •diagnosed with ASD given by registered psychiatrists or clinical psychologists according to the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) criteria of ASD
  • •IQ score above 60
  • •able to communicate in Chinese

排除标准

  • •with severe motor dysfunctions
  • •history of other neurological and psychiatric disorders or head trauma

研究组 & 干预措施

Active-tDCS

Experimental

For active-tDCS condition, participants will receive stimulation on the dorsolateral prefrontal cortex with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds.

干预措施: tDCS with computerized cognitive training (Device)

Sham-tDCS

Sham Comparator

For sham-tDCS condition, participants will receive initial stimulation with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp then it will be discontinued.

干预措施: tDCS with computerized cognitive training (Device)

结局指标

主要结局

Average standardised score of executive function tests

时间窗: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)

The executive function of the children with ASD will be assessed using the Executive Composite score, which will be derived by summing the scores from the test battery of executive functions. Simple-task processing speed will be evaluated using the CANTAB® 5-choice Reaction Time (RTI) task. Complex-task processing speed will be assessed using the computerized version of the Wisconsin Card Sorting Test (WCST). The mean reaction time is calculated for the trials giving a correct answer during WCST. The reaction time measured from both tasks will be converted to standard scores and averaged to yield an executive composite score. Lower scores indicate poorer executive functioning.

次要结局

  • Change in CANTAB® cognitive test - Emotion Recognition Task (ERT)(First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks))
  • Change in CANTAB® cognitive test - Reaction Time (RTI)(First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months))
  • Change in CANTAB® cognitive test - Stop Signal Task (SST)(First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months))
  • Change in CANTAB® cognitive test - Multitasking Test (MTT): Response Latencies(First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months))
  • Change in CANTAB® cognitive test - Multitasking Test (MTT): Error Scores(First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months))
  • Change in CANTAB® cognitive test - Emotion Recognition Task (ERT)(First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months))
  • Change in Verbal Fluency Test (VFT)(First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Yvonne Han

Associate Professor

The Hong Kong Polytechnic University

研究点 (1)

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