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
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

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
Backup
Melody Chan, PhD
mei-yan-melody.chan@connect.polyu.hk
Time Frame
Start Date: 2022-06-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Active cathodal (inhibitory) tDCS vs. Sham-tDCS condition
Experimental group: active multisession tDCS + active booster tDCS vs Active control group: sham multisession tDCS + sham booster tDCS~To test whether active cathodal \[inhibitory\] tDCS over the left dlPRC will facilitate learning through stimulation and thus improve cognitive function in patients with ASD, the primary outcomes (SRS-2 scores) of the two groups at the start (T0), 1-month (T1), 3-month (T2), 6-month (T3), and at the end of study i.e. 12-months (T4) will be compared.
Experimental: Active booster tDCS treatment vs. Sham booster tDCS treatment
Experimental group: active multisession tDCS + active booster tDCS vs Active control group: active multisession tDCS + sham booster tDCS~To test whether booster treatment cycles of tDCS will prolong the cognitive benefits in individuals with ASD), the primary outcome, the total SRS-2 score, and the secondary outcomes, the E/I ratio and the cognitive composite score at the start (T0), 1-month (T1), 3-month (T2), 6-month (T3), and at the end of study i.e. 12-months (T4), will be compared.
Experimental: Change in EEG E/I ratios in the active tDCS vs. sham tDCS groups
Experimental group: active multisession tDCS + active booster tDCS vs Active control group: sham multisession tDCS + sham booster tDCS~To test whether enhanced neuronal network organization, as indicated by EEG E/I ratios, in patients with ASD will mediate the beneficial effects of tDCS in terms of improvements in cognitive function, measurements taken at baseline, 1-day and 1-month after tDCS treatment will be compared. The change in EEG E/I ratios in patients in the active tDCS and sham tDCS groups will be compared using E/I ratios averaged from channels Fp1, F3, and F7 to increase the signal-to-noise ratio of the EEG data and to represent the left frontal E/I ratio.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov