Clinical trial NCT06880159: Transcranial Direct Current Stimulation in Children with Autism Spectrum Disorder
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children with Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Transcranial Direct Current Stimulation (tDCS)
Electroencephalography
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, 100 adolescents with ASD (age 8-12 years) will be randomly assigned to active- (n=50), or sham- (n=50) tDCS groups. Twenty-minute sessions of 1.5 mA tDCS stimulation to the left dorsolateral prefrontal cortex (DLPRC) in conjunction with cognitive training exercise will be provided on 10 consecutive weekdays. EEGs and neuropsychological tests will be administered before and immediate after the series of tDCS sessions.

Hypothesis: We 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, we 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, we will report them as such in presentations and published papers, and we 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.


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

Primary outcomes:
measure: Average standardised score of executive function tests
timeFrame: First day of intervention, 1 day after the last day of intervention (2 time points, up to 2 weeks)
Secondary outcomes:
measure: Change in CANTAB® cognitive test - Reaction Time (RTI)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
measure: Change in CANTAB® cognitive test - Stop Signal Task (SST)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
measure: Change in CANTAB® cognitive test - Multitasking Test (MTT)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
measure: Change in CANTAB® cognitive test - Emotion Recognition Task (ERT)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
Other outcomes:
measure: Exploratory mediator - excitability-inhibitory (E/I) ratio (indexed by EEG measures)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yvonne Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: