NCT05492032

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

Cumulative and Booster Effects of Multisession Prefrontal Transcranial Direct-Current Stimulation (tDCS) on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcranial Direct Current Stimulation
• Autistic Spectrum Disorder
• Electroencephalography
• Booster Effects

Interventions

Type	Name	Description
DEVICE	Active-tDCS	For active-tDCS condition, participants will receive stimulation on the dorsolateral prefrontal cortex with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds. Following that, a twenty-minute executive functional training task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the training task ends.
DEVICE	Sham-tDCS	For sham-tDCS condition, participants will receive initial stimulation with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp then it will be discontinued. Participants will also receive the twenty-minute executive functional training task five minutes subsequent to the stimulation mode.
BEHAVIORAL	Cognitive training	Participants will complete an online cognitive training program consisting of 10 consecutive daily weekday training sessions while they receive either the active or sham tDCS stimulation. Each training session will last for 20 minutes. The online cognitive training program will comprise five exercises assessing information processing speed and executive function capacities. Each exercise will take approximately 4 minutes to complete. Given many studies, across different neurological/neuropsychiatric diagnoses, especially for people with autism, it has long been established that social skills and functioning are closely related, and multiple studies have shown that executive function training can improve social functioning in autism or vice versa (i.e. social skills training improves executive functioning in autism), it is reasonable to include cognitive training in this tDCS protocol.

Timeline

• Start date: 2022-06-02
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2022-08-08
• Last updated: 2025-11-26

Locations

1 site across 1 country: Hong Kong