Clinical trial NCT05492032: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Autistic Spectrum Disorder
Electroencephalography
Booster Effects
Keywords: Autism
ASD
tDCS
Treatment outcome
EEG
E/I ratio
Booster effects
Cognitive function
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a one-year parallel design (triple-arm), double-blind RCT. Participants will be randomly assigned to receive either (1) active daily tDCS with computerized executive function training in weeks 0-2, followed by active bimonthly booster tDCS sessions in weeks 3-14, and active monthly booster tDCS sessions in weeks 15-52; (2) active daily tDCS with computerized executive function training in weeks 0-2, followed by sham bimonthly booster tDCS sessions in weeks 3-14, and sham monthly booster tDCS sessions in weeks 15-52, or sham daily tDCS with computerized executive function training in weeks 0-2, followed by sham bimonthly booster tDCS sessions in weeks 3-14, and sham monthly booster tDCS sessions in weeks 15-52.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
timeFrame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Secondary outcomes:
measure: tDCS safety and clinical response in tDCS outcome
timeFrame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
measure: Change in neuropsychological measures - CANTAB® cognitive tests
timeFrame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
measure: Change in EEG E/I ratio measurement
timeFrame: First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points)
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yvonne Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: