Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder

NCT06880159 | Recruiting

• 1 other identifier: HSEARS20250123005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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, 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

Autism Spectrum Disorder (ASD); Transcranial Direct Current Stimulation (tDCS); Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Average standardised score of executive function tests

  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.

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

Secondary Outcomes (6)

• 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)

Other Outcomes (2)

• Exploratory mediator - excitability-inhibitory (E/I) ratio (indexed by EEG measures)

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

• Oxyhemoglobin Concentration (measured by fNIRS)

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

Study Arms (2)

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.

Device: tDCS with computerized cognitive training

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.

Device: tDCS with computerized cognitive training

Interventions

tDCS with computerized cognitive training DEVICE

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.

Active-tDCS; Sham-tDCS

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yvonne Han, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Han, PhD

CONTACT

+852 2766 7578; yvonne.han@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

HK (1)