Resting-State Functional Connectivity as a Predictor of tDCS Effects in Adolescents With Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tDCS.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS), Electroencephalography. Basic parameters: 12 years — 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device tDCS
Participant will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS. The order of the conditions will be randomized and counterbalanced across participants, and the three stimulation conditions will be administered at least a week apart to avoid carry-over effects. The tDCS session will last for 20 minutes.
Primary outcome measures
- Change in CANTAB® cognitive test - Reaction Time (RTI) [Time frame: During each stimulation session, last around 3mins]
- Change in CANTAB® cognitive test - Spatial Working Memory (SWM) [Time frame: During each stimulation session, last around 6mins]
- Change in CANTAB® cognitive test - Multitasking Test (MTT): Response Latencies [Time frame: During each stimulation session, last around 8mins]
- Change in CANTAB® cognitive test - Multitasking Test (MTT): Error Scores [Time frame: During each stimulation session, last around 8mins]
- Changes in EEG theta coherence [Time frame: Before tDCS session, Right after tDCS session (2 timepoints, up to 20 minutes)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hung Hom
Identifiers
NCT: NCT06878326 · HSEARS20250212003