Autism Spectrum Disorder (ASD)NCT06880159
Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder
A study testing tDCS with computerized cognitive training in people with Autism Spectrum Disorder (ASD) and Transcranial Direct Current Stimulation (tDCS), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS), Electroencephalography
- What is being tested?
- tDCS with computerized cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- with severe motor dysfunctions
- history of other neurological and psychiatric disorders or head trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon
Yvonne Han, PhD, +852 2766 7578, yvonne.han@polyu.edu.hk
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder
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.
Read more
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
- Being tested
- tDCS with computerized cognitive training
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS with computerized cognitive trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS with computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
RTI assesses motor and mental response speeds, reaction time, response accuracy and impulsivity. It consists of 30 trials with five potential targets and requires participants to make flexible responses as fast as possible to the target stimulus (shown in yellow). Specifically, movement and reaction time will be measured, where shorter duration reflects faster processing speed.
Measured: 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)
SST assesses the ability of inhibition control. The participant must respond to an arrow stimulus, by selecting one of two options, depending on the direction in which the arrow points. If an audio tone is present, the subject must withhold making that response (inhibition). Accuracy will be measured, where higher accuracy indicates better inhibition control.
Measured: 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
MTT assesses the ability to resolve the interference of task-irrelevant information (stroop-like effect). The test displays an arrow which can appear on either the left or right side of the screen and can point to either the left or right side. In each trial, participants are presented with a cue that indicates which button to press according to two different rules. And the rules that participants have to follow may change from trial to trial in a randomized order. Participant's response latencies will be measured.
Measured: 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
MTT assesses the ability to resolve the interference of task-irrelevant information (stroop-like effect). The test displays an arrow which can appear on either the left or right side of the screen and can point to either the left or right side. In each trial, participants are presented with a cue that indicates which button to press according to two different rules. And the rules that participants have to follow may change from trial to trial in a randomized order. Participant's error scores will be measured.
Measured: 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)
ERT assesses ability to identify six basic emotions in facial expressions along a continuum of expression magnitude. The participants must select which emotion the facial image displayed 0.2s ago. Accuracy and its percentage, as well as response latencies will be measured.
Measured: 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)
The VFT assesses an individual's ability of working memory retrieval and executive control by instructing the individual to generate words for given semantic categories within a limited time. The VFT experimental paradigm is designed and presented with E-prime 3 (Psychology Software Tools Inc., Sharpsburg, PA, USA). During the experimental blocks, which will be counterbalanced across individuals to avoid order effects, a category word (i.e. 'transportation' or 'country') will be shown on the screen. Participants will be asked to focus their eye gaze on the center of the screen and continuously repeat '1, 2, 3, 4' slowly during the given period of time. Their responses will be recorded by an audio recorder and then transferred into written form on an Excel spreadsheet. The number of unique and correct words generated will be counted for each of the participants. This test will be paired with fNIRS recording.
Measured: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yvonne Han, The Hong Kong Polytechnic University
- Investigators
- Yvonne Han, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880159
- Sponsor's protocol ID
- HSEARS20250123005
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06880159
- Acronym / sponsor ID
- HSEARS20250123005
- Conditions
- Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS), Electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-tDCS | Experimental | Device: tDCS with computerized cognitive trainingFor 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. |
| Sham-tDCS | Sham comparator | Device: tDCS with computerized cognitive trainingFor 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- with severe motor dysfunctions
- history of other neurological and psychiatric disorders or head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS with computerized cognitive trainingParticipants 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. | Device | Active-tDCS, Sham-tDCS |
Primary outcome
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)
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.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yvonne Han, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS with computerized cognitive training in people with Autism Spectrum Disorder (ASD) and Transcranial Direct Current Stimulation (tDCS), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Han, PhD (+852 2766 7578, yvonne.han@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.