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

Official title

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

Overview

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.

Interventions

• 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/neuropsychia

Primary outcome measures

• Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) [Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)]

Secondary outcome measures (3)

• tDCS safety and clinical response in tDCS outcome [Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)]
• Change in neuropsychological measures - CANTAB® cognitive tests [Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)]
• Change in EEG E/I ratio measurement [Time frame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Hung Hom

Identifiers

NCT: NCT05492032 · HSEARS20220216004-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗