NCT06878326 Resting-State Functional Connectivity as a Predictor of tDCS Effects in Adolescents With Autism Spectrum Disorder
| NCT ID | NCT06878326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Autism Spectrum Disorder (ASD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-09-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD, (2) to better understand the neural mechanisms underlying the neuromodulation effects of tDCS in patients with ASD, and (3) to determine whether resting-state functional connectivity measures can predict the therapeutic effects of active tDCS in individuals with ASD. Methods: To assess the therapeutic effects and neural mechanisms of tDCS, 90 adolescents with ASD (age 12-22 years) will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS with at least a week apart each time. During the active tDCS or sham-tDCS condition, the participants will be administered a computerized test battery (Cambridge Neuropsychological Test Automated Battery, CANTAB®) to evaluate their cognitive function. EEG before and after the tDCS to evaluate the tDCS-induced alteration in their neural activity and functional connectivity. Hypothesis: Drawing together the different evidence linking ASD with cortical hyper-excitability and disordered neural connectivity, as reviewed previously, the investigators hypothesize that, relative to a sham-tDCS condition, active cathodal (inhibitory) and anodal (excitatory) tDCS over the left DLPRC will induce stimulation-linked facilitation of learning and resultant improvement of cognitive functioning in patients with ASD. In addition to the therapeutic effects of tDCS, enhanced neural connectivity, as indexed by altered level EEG theta coherence in patients with ASD, will mediate the beneficial effects of tDCS, relative to sham tDCS, on improvements in cognitive function. Moreover, resting-state functional connectivity will moderate the beneficial effects of active tDCS on cognitive function, relative to sham tDCS, such that participants with greater pre-treatment resting state functional connectively will evidence greater/less response to tDCS, relative to participants receiving sham tDCS.
Eligibility Criteria
Inclusion Criteria: * being 12-22 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 * able to communicate in Chinese Exclusion Criteria: * without a confirmed diagnosis from the clinical psychologist * history of other neurological and psychiatric disorders and head trauma * on psychiatric medication
Contact & Investigator
Yvonne Han, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT06878326 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 22 Years, studying Autism Spectrum Disorder (ASD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06878326 currently recruiting?
Yes, NCT06878326 is actively recruiting participants. Contact the research team at yvonne.han@polyu.edu.hk for enrollment information.
Where is the NCT06878326 trial being conducted?
This trial is being conducted at Hung Hom, Hong Kong.
Who is sponsoring the NCT06878326 clinical trial?
NCT06878326 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Yvonne Han, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 90 participants.