跳至主要内容
临床试验/NCT05035511
NCT05035511招募中不适用

A Machine Learning Approach for Predicting tDCS Treatment Outcomes of Adolescents With Autism Spectrum Disorders

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: 2022年1月5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
Change in behavioral measures (social communication and restricted repetitive behavior) - Social Responsiveness Scale-2nd edition (SRS-2)

研究概览

简要总结

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities.

Fundamental to these cognitive and behavioral problems is the disordered cortical connectivity and resultant executive dysfunction that underpin the use of effective strategies to integrate information across contexts. Brain connectivity problems affect the rate at which information travels across the brain. Slow processing speed relates to a reduced capacity of executive function to recall and formulate thoughts and actions automatically, with the result that autistic children with poor processing speed have great difficulty learning or perceiving relationships across multiple experiences. In consequence, these children compensate for the impaired ability to integrate information from the environment by memorizing visual details or individual rules from each situation. This explains why children with autism tend to follow routines in precise detail and show great distress over seemingly trivial changes in the environment.

To date, there is no known cure for ASD, and the disorder remains a highly disabling condition. Recently, a non-invasive brain stimulation technique, transcranial direct current Stimulation (tDCS) has shown great promise as a potentially effective and costeffective tool for reducing core symptoms such as anxiety, aggression, impulsivity, and inattention in patients with autism. This technique has been shown to modify behavior by inducing changes in cortical excitability and enhancing connectivity between the targeted brain areas. However, not all ASD patients respond to this intervention the same way and predicting the behavioral impact of tDCS in patients with ASD remains a clinical challenge. This proposed study thus aims to address these challenges by determining whether resting-state EEG and clinical data at baseline can be used to differentiate responders from non-responders to tDCS treatment. Findings from the study will provide new guidance for designing intervention programs for individuals with ASD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
  • •Individuals with intelligence quotient above
  • •Individuals who demonstrate the ability to comprehend testing and stimulation instructions.

排除标准

  • •Individuals with severe motor dysfunctions that would hinder their participation, and those with history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study

研究组 & 干预措施

Responders vs Non-responders

Experimental

After the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score (primary outcome). Participants that show reductions of at least 10% in the total SRS scores as compared to baseline scores will be considered responders.

干预措施: tDCS (Device)

结局指标

主要结局

Change in behavioral measures (social communication and restricted repetitive behavior) - Social Responsiveness Scale-2nd edition (SRS-2)

时间窗: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)

SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. After the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score (primary outcome). Participants that show reductions of at least 10% in the total SRS scores as compared to baseline scores will be considered responders.

次要结局

  • Change in CANTAB® cognitive tests - Emotion Recognition Task (ERT)(Day 1 of intervention, and 1 day after the last day of intervention (2 time points))
  • Change in CANTAB® cognitive tests - Stop Signal Task (SST)(Day 1 of intervention, and 1 day after the last day of intervention (2 time points))
  • ASD symptomatology - The Autism Diagnostic Interview-Revised (ADI-R)(Day 1 of intervention (1 time point))
  • Change in Neurophysiological measures(Day 1 of intervention, and 1 day after the last day of intervention (2 time points))
  • Change in CANTAB® cognitive tests - Multitasking Test (MTT)(Day 1 of intervention, and 1 day after the last day of intervention (2 time points))

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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