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Clinical Trials/NCT05492032
NCT05492032
Recruiting
N/A

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

The Hong Kong Polytechnic University1 site in 1 country150 target enrollmentJune 2, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Transcranial Direct Current Stimulation
Sponsor
The Hong Kong Polytechnic University
Enrollment
150
Locations
1
Primary Endpoint
Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2022
End Date
December 31, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Yvonne Han

Associate Professor, Department of Rehabilitation Sciences

The Hong Kong Polytechnic University

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.

Outcomes

Primary Outcomes

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)

SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. SRS-2 assessments will be conducted before and immediately after tDCS treatment.

Secondary Outcomes

  • tDCS safety and clinical response in tDCS outcome(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(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(First day of intervention, 1-month, 3-month, 6-month and 12-months after treatment (5 time points))

Study Sites (1)

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