NCT05492032 Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct Current Stimulation in Adolescents With ASD

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This trial targets 150 participants in total. It began in 2022-06-02 with a primary completion date of 2026-09-30.

Brief Summary

Autism spectrum disorder (ASD) is a pervasive and lifelong developmental disorder that currently affects 1 in 54 children. Individuals with autism are often severely impaired in communication, social skills, and cognitive functions. Particularly detrimental characteristics typical of ASD include the inability to relate to people and the display of repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. To date, there is no cure for ASD, and the disorder remains a highly disabling condition. Recently, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, has shown great promise as an effective and cost-effective tool for reducing core symptoms, such as anxiety, aggression, impulsivity, and poor social communication, in patients with autism. Although the empirical findings in patients with ASD are encouraging, it remains to be determined whether these experimental data can be translated into real-world benefits. An important next step is to better understand the factors affecting the long-term efficacy of tDCS treatment - in particular, the possible risk factors associated with relapse in patients with ASD and the role of booster session tDCS as an add-on treatment to induce long-lasting neuroplastic effects in ASD.

Eligibility Criteria

Inclusion Criteria: * Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R). * Individuals with ASD who are comorbid with ADHD symptoms will be included if they were willing to abstain from the use of these medications at least 96 hours before the commencement, until the completion, of the treatment. * In view of the fact that neuroadaptation to antipsychotics typically occurs within six months, potential participants who are prescribed antipsychotic medications will only be included if the dosage of the medication remained unchanged for six months or more before the experimental period. Exclusion Criteria: * Individuals without a confirmed diagnosis from the clinical psychologist, with a history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study. * In view of the possibility of seizure induction by tDCS, potential ASD participants comorbid with epilepsy will be excluded. * Potential participants comorbid with mood or anxiety disorders will also be excluded.

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