Actively Recruiting

Phase Not Applicable
Age: 8Years - 12Years
All Genders
NCT06880159

Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder

Led by The Hong Kong Polytechnic University · Updated on 2026-02-06

90

Participants Needed

1

Research Sites

143 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder

Who Can Participate

Age: 8Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 8 and 12 years old
  • Diagnosed with autism spectrum disorder by a registered psychiatrist or clinical psychologist according to DSM-5 criteria
  • Have an IQ score above 60
  • Be able to communicate in Chinese
Not Eligible

You will not qualify if you...

  • Have severe motor dysfunctions
  • Have a history of other neurological or psychiatric disorders or head trauma

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Actively Recruiting

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Research Team

Y

Yvonne Han, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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