Actively Recruiting

Phase Not Applicable
Age: 12Years - 21Years
All Genders
ID06272669

Cumulative and Booster Effects of Multisession Prefrontal tDCS on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder

Led by The Hong Kong Polytechnic University · Updated on 2025-11-21

90

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 neurodevelopmental condition marked by challenges in communication, social skills, and behavior. Researchers are evaluating the effects of transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, to improve cognitive and social functions in adolescents with ASD. The study aims to understand how tDCS may affect brain mechanisms and assess if booster sessions can enhance and prolong benefits. Participants will receive either active or sham tDCS targeting the left dorsolateral prefrontal cortex, applied during executive function training tasks over 10 sessions within two weeks. The active stimulation involves 20 minutes of current, while the sham group experiences brief initial stimulation only. Responders will enter a six-month follow-up phase receiving randomized booster sessions of active or sham tDCS bi-monthly for three months, then monthly for another three months. During the trial, participants will be assessed using the Social Responsiveness Scale and neuropsychological cognitive tests at multiple time points up to 26 weeks. Researchers will monitor social responsiveness changes and clinical responses to tDCS. The study includes careful monitoring of cognitive and social improvements, with evaluations before, during, and after treatment to understand the lasting effects and safety of tDCS in ASD adolescents.

CONDITIONS

Brief Title

Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents

Who Can Participate

Age: 12Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals diagnosed with autism spectrum disorder by a clinical psychologist using DSM-V criteria
  • Diagnosis confirmed through structured interview with parents or primary caregivers using Autism Diagnostic Interview-Revised (ADI-R)
Not Eligible

You will not qualify if you...

  • Individuals without a confirmed diagnosis from a clinical psychologist
  • History of other neurological or psychiatric disorders
  • History of head trauma
  • Currently taking psychiatric medication

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)

Treatment

Duration - 2 weeks

Participants receive either active or sham transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex during 10 sessions over 2 weeks while performing executive function training tasks. They will undergo both active and sham conditions in a crossover design.

10 visits over 2 weeks

Follow-up

Duration - 6 months

Participants who respond to treatment are enrolled in a 6-month follow-up phase with bimonthly and monthly 20-minute booster tDCS or sham sessions to assess the booster effects on cognitive and social impairments.

Up to 9 booster sessions over 6 months

Trial Site Locations

Total: 1 location

1

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong, Hong Kong

Actively Recruiting

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Research Team

Y

Yvonne Han, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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