Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD).

Objective: (1) To assess the therapeutic effects of tDCS when combined with cognitive training for 10 consecutive weekdays on improving cognitive processing in children with ASD, relative to control group receiving sham-stimulation, and (2) to evaluate the associated neural mechanisms underlying the treatment effect of tDCS on children with ASD.

Methods: To assess the therapeutic effects of tDCS, 100 adolescents with ASD (age 8-12 years) will be randomly assigned to active- (n=50), or sham- (n=50) tDCS groups. Twenty-minute sessions of 1.5 mA tDCS stimulation to the left dorsolateral prefrontal cortex (DLPRC) in conjunction with cognitive training exercise will be provided on 10 consecutive weekdays. EEGs and neuropsychological tests will be administered before and immediate after the series of tDCS sessions. Hypothesis: The investigators hypothesize that children with ASD who are randomly assigned to receive a montage of prefrontal tDCS, with cathode (inhibitory) placed over left DLPFC and anode (excitatory) over right supraorbital region) will evidence greater improvement in executive function (primary outcome) than children with ASD who are randomly assigned to receive sham-tDCS. In addition to testing the primary clinical outcome, stated above, in planned exploratory analyses, the investigators will also examine the effects of tDCS on secondary outcome measures of cognitive function, including information processing speed, working memory, inhibitory control, and cognitive flexibility; and conduct exploratory mediation analyses to better understand the potential neurophysiological factors underlying the therapeutic effects of tDCS. This will include E/I ratio as exploratory mediator variables. As these secondary analyses are exploratory, the investigators will report them as such in presentations and published papers, and the investigators will not draw definitive conclusions from them. Rather, they will be used to better understand the potential impact of tDCS and the mechanisms underlying impact, and to inform future research.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 12
Healthy Volunteers: f
View:

• being 8-12 years old

• diagnosed with ASD given by registered psychiatrists or clinical psychologists according to the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) criteria of ASD

• IQ score above 60

• able to communicate in Chinese

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hung Hom
Contact Information
Primary
Yvonne Han, PhD
yvonne.han@polyu.edu.hk
+852 2766 7578
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 100
Treatments
Experimental: 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.
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov