Actively Recruiting
Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct-Current Stimulation on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder
Led by The Hong Kong Polytechnic University · Updated on 2025-11-26
150
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autism spectrum disorder (ASD) is a lifelong developmental condition affecting communication, social skills, and cognitive functions, often causing emotional stress for individuals and their communities. This research investigates the use of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, to study its effects on reducing core ASD symptoms such as anxiety, aggression, impulsivity, and social difficulties. The trial aims to understand the long-term benefits of tDCS and whether booster sessions can help maintain improvements in adolescents with ASD. Participants receive either active or sham (placebo) multisession tDCS targeting the left dorsolateral prefrontal cortex, combined with an online cognitive training program focused on executive functions. The study compares groups receiving active multisession tDCS plus active booster sessions against those receiving sham multisession and booster tDCS, and also examines the role of booster treatments in sustaining cognitive benefits. Each tDCS session involves a brief stimulation causing a tingling sensation, followed by a 20-minute cognitive training task. The study duration includes assessments at baseline, and at 1, 3, 6, and 12 months after treatment. During the study, participants undergo repeated evaluations including the Social Responsiveness Scale-2 (SRS-2) to measure social function changes, cognitive tests, and EEG recordings to assess brain activity changes. Safety and clinical responses to tDCS are monitored at multiple time points. The trial uses a randomized, triple-blind design to ensure unbiased results. Overall participation lasts up to 12 months, with multiple follow-up visits to track sustained effects and potential relapse risks.
CONDITIONS
Brief Title
Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct Current Stimulation in Adolescents With ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals diagnosed with autism spectrum disorder based on DSM-5 criteria confirmed by a clinical psychologist
- Participants diagnosed using Autism Diagnostic Interview-Revised (ADI-R) with their parents or caregivers
- Individuals with ASD and ADHD symptoms willing to stop ADHD medications at least 96 hours before and during treatment
- Participants on antipsychotic medications must have stable doses for six months or more before the study
You will not qualify if you...
- Individuals without a confirmed ASD diagnosis or with other neurological or psychiatric disorders
- Those with a history of head trauma or currently taking psychiatric medication
- Participants with epilepsy or seizure history
- Individuals with mood or anxiety disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 consecutive weekdays
Participants receive multisession prefrontal transcranial direct current stimulation (tDCS) combined with cognitive training over 10 consecutive weekdays. Each session includes active or sham tDCS followed by a 20-minute executive functional training task.
10 daily visits (in-person or online)
Duration - 12 months
Participants undergo booster tDCS treatments and assessments to monitor cognitive and social function improvements and safety over 12 months after the initial treatment.
5 visits (at 1, 3, 6, and 12 months post-treatment plus baseline)
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University
Hung Hom, Kowloon, Hong Kong
Actively Recruiting
Research Team
Y
Yvonne Han, PhD
M
Melody Chan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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