Actively Recruiting

Phase Not Applicable
Age: 12Years - 21Years
All Genders
ID05492032

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

Age: 12Years - 21Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Follow-up

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

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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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