Transcranial Direct Current StimulationNCT05035511
A Machine Learning Approach for Predicting tDCS Treatment Outcomes of Adolescents With Autism Spectrum Disorders
A study testing tDCS in people with Transcranial Direct Current Stimulation and Autistic Disorders Spectrum, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Autistic Disorders Spectrum, Electroencephalography
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jan 2022to 31 Dec 2026
- 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 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
- Individuals with intelligence quotient above 60.
- Individuals who demonstrate the ability to comprehend testing and stimulation instructions.
Who cannot join
- Individuals with severe motor dysfunctions that would hinder their participation, and those with history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melody Chan, PhD contact
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon
Yvonne Han, PhD, 27667578, yvonne.han@polyu.edu.hk
Melody Chan, PhD, mei-yan-melody.chan@connect.polyu.hk
About this study
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities.
Fundamental to these cognitive and behavioral problems is the disordered cortical connectivity and resultant executive dysfunction that underpin the use of effective strategies to integrate information across contexts. Brain connectivity problems affect the rate at which information travels across the brain. Slow processing speed relates to a reduced capacity of executive function to recall and formulate thoughts and actions automatically, with the result that autistic children with poor processing speed have great difficulty learning or perceiving relationships across multiple experiences. In consequence, these children compensate for the impaired ability to integrate information from the environment by memorizing visual details or individual rules from each situation. This explains why children with autism tend to follow routines in precise detail and show great distress over seemingly trivial changes in the environment.
To date, there is no known cure for ASD, and the disorder remains a highly disabling condition. Recently, a non-invasive brain stimulation technique, transcranial direct current Stimulation (tDCS) has shown great promise as a potentially effective and costeffective tool for reducing core symptoms such as anxiety, aggression, impulsivity, and inattention in patients with autism. This technique has been shown to modify behavior by inducing changes in cortical excitability and enhancing connectivity between the targeted brain areas. However, not all ASD patients respond to this intervention the same way and predicting the behavioral impact of tDCS in patients with ASD remains a clinical challenge. This proposed study thus aims to address these challenges by determining whether resting-state EEG and clinical data at baseline can be used to differentiate responders from non-responders to tDCS treatment. Findings from the study will provide new guidance for designing intervention programs for individuals with ASD.
- Conditions
- Transcranial Direct Current Stimulation, Autistic Disorders Spectrum, Electroencephalography, Machine Learning
- Being tested
- tDCS
- Medical subject headings
- Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Active-tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive active tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program is comprised of 5 exercises targeting at information processing speed and executive function capacities. Each exercise lasts for approximately 4 minutes, totaling approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Responders vs Non-responders | Experimental | After the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score (primary outcome). Participants that show reductions of at least 10% in the total SRS scores as compared to baseline scores will be considered responders. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in behavioral measures (social communication and restricted repetitive behavior) - Social Responsiveness Scale-2nd edition (SRS-2)
SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. After the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score (primary outcome). Participants that show reductions of at least 10% in the total SRS scores as compared to baseline scores will be considered responders.
Measured: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Secondary outcomes (5)
ASD symptomatology - The Autism Diagnostic Interview-Revised (ADI-R)
ADI-R is a semi-structured interview conducted with parents, which consists of detailed questions about early developmental and current functioning of the child. It consists of three scales, Social Interaction, Communication, and Repetitive/Stereotyped Behavior. An autism diagnosis is indicated when scores in all three behavioral areas meet the specified minimum cutoff scores, with higher scores indicating more severe autistic features.
Measured: Day 1 of intervention (1 time point)
Change in CANTAB® cognitive tests - Multitasking Test (MTT)
Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance.
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 and error scores will be measured.
Measured: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Change in CANTAB® cognitive tests - Stop Signal Task (SST)
SST assesses a participants' motor inhibition of a prepotent response. The participant is required to 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 the response.
Measured: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Change in CANTAB® cognitive tests - Emotion Recognition Task (ERT)
ERT assesses emotional recognition ability of an individual. The participant is required to determine the emotion of the face displayed from 6 options (i.e. sadness, happiness, fear, anger, disgust or surprise) after viewing the facial features of real individuals for 200 milliseconds.
Measured: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Change in Neurophysiological measures
EEG resting-state theta coherence (4-7.5 Hz) will be computed from EEG signals collected from the 19 electrode positions (Fp1, Fp2, F3, F4, F7, F8, Fz, T3, T4, T5, T6, C3, C4, Cz, P3, P4, Pz, O1, and O2). Four mean coherence values will be computed, including two intra-hemispheric theta coherence values (intra-left frontoposterior: F7-P3, F7-O1, F3-P3, F3-O1; and intra-right frontoposterior: F8-P4, F8-O2, F4-P4, F4-O2); and two inter-hemispheric theta coherence values (inter-frontal: F3-F4, F7-F8, F3-F8, F4-F7; and inter-frontoposterior: F7-P4, F7-O2, F3-P4, F3-O2, F8-P3, F8-O1, F4-P3 and F4-O1). Each coherence value will then be transformed using Fisher's Z-transformation.
Measured: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- 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
- NCT05035511
- Sponsor's protocol ID
- HSEAR20201118003-01
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan MMY, Wong KL, Shea CKS, Saxena D, Cheung MC, Chan AS, Han YMY. Baseline symptom severity and response to multisession cathodal transcranial direct current stimulation in adolescents and young adults with autism: an exploratory analysis. J Psychiatr Res. 2026 Jul;198:203-209. doi: 10.1016/j.jpsychires.2026.03.043. Epub 2026 Mar 26.
PubMed 41921246
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Approach for Predicting tDCS Treatment Outcomes of Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05035511
- Acronym / sponsor ID
- HSEAR20201118003-01
- Conditions
- Transcranial Direct Current Stimulation, Autistic Disorders Spectrum, Electroencephalography, Machine Learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2021 (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.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities.
Fundamental to these cognitive and behavioral problems is the disordered cortical connectivity and resultant executive dysfunction that underpin the use of effective strategies to integrate information across contexts. Brain connectivity problems affect the rate at which information travels across the brain. Slow processing speed relates to a reduced capacity of executive function to recall and formulate thoughts and actions automatically, with the result that autistic children with poor processing speed have great difficulty learning or perceiving relationships across multiple experiences. In consequence, these children compensate for the impaired ability to integrate information from the environment by memorizing visual details or individual rules from each situation. This explains why children with autism tend to follow routines in precise detail and show great distress over seemingly trivial changes in the environment.
To date, there is no known cure for ASD, and the disorder remains a highly disabling condition. Recently, a non-invasive brain stimulation technique, transcranial direct current Stimulation (tDCS) has shown great promise as a potentially effective and costeffective tool for reducing core symptoms such as anxiety, aggression, impulsivity, and inattention in patients with autism. This technique has been shown to modify behavior by inducing changes in cortical excitability and enhancing connectivity between the targeted brain areas. However, not all ASD patients respond to this intervention the same way and predicting the behavioral impact of tDCS in patients with ASD remains a clinical challenge. This proposed study thus aims to address these challenges by determining whether resting-state EEG and clinical data at baseline can be used to differentiate responders from non-responders to tDCS treatment. Findings from the study will provide new guidance for designing intervention programs for individuals with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Responders vs Non-responders | Experimental | Device: tDCSAfter the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score (primary outcome). Participants that show reductions of at least 10% in the total SRS scores as compared to baseline scores will be considered responders. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
- Individuals with intelligence quotient above 60.
- Individuals who demonstrate the ability to comprehend testing and stimulation instructions.
Key exclusion criteria (1 listed)
- Individuals with severe motor dysfunctions that would hinder their participation, and those with history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study
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 |
|---|---|---|
| tDCSActive-tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive active tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program is comprised of 5 exercises targeting at information processing speed and executive function capacities. Each exercise lasts for approximately 4 minutes, totaling approximately 20 minutes. | Device | Responders vs Non-responders |
Primary outcome
Change in behavioral measures (social communication and restricted repetitive behavior) - Social Responsiveness Scale-2nd edition (SRS-2)
Time frame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. After the tDCS outcome recorded immediately after tDCS treatment, participants will be categorized into responders and non-responders based on the percentage of change in the total SRS score (primary outcome). Participants that show reductions of at least 10% in the total SRS scores as compared to baseline scores will be considered responders.
5 secondary outcomes
ASD symptomatology - The Autism Diagnostic Interview-Revised (ADI-R)
Time frame: Day 1 of intervention (1 time point)
Change in CANTAB® cognitive tests - Multitasking Test (MTT)
Time frame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Change in CANTAB® cognitive tests - Stop Signal Task (SST)
Time frame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Change in CANTAB® cognitive tests - Emotion Recognition Task (ERT)
Time frame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Change in Neurophysiological measures
Time frame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
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 24 Jun 2026.
- Derived from this study: PubMed 41921246Chan MMY, Wong KL, Shea CKS, Saxena D, Cheung MC, Chan AS, Han YMY. Baseline symptom severity and response to multisession cathodal transcranial direct current stimulation in adolescents and young adults with autism: an exploratory analysis. J Psychiatr Res. 2026 Jul;198:203-209. doi: 10.1016/j.jpsychires.2026.03.043. Epub 2026 Mar 26.
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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.
Melody Chan, PhD contact
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 in people with Transcranial Direct Current Stimulation and Autistic Disorders Spectrum, 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 3 inclusion and 1 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 24 Jun 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. 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 (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?
Change in behavioral measures (social communication and restricted repetitive behavior) - Social Responsiveness Scale-2nd edition (SRS-2) (time frame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035511, which also lists 1 linked publication.
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 24 Jun 2026.