Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tDCS with computerized cognitive training.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS), Electroencephalography. Basic parameters: 8 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder
Overview
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.
Interventions
- Device tDCS with computerized cognitive training
Participants will complete tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. The training session will last for 20 minutes.
Primary outcome measures
- Average standardised score of executive function tests [Time frame: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Secondary outcome measures (6)
- Change in CANTAB® cognitive test - Reaction Time (RTI) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- with severe motor dysfunctions
- history of other neurological and psychiatric disorders or head trauma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hung Hom
Identifiers
NCT: NCT06880159 · HSEARS20250123005