Clinical trial NCT05035511: A Machine Learning Approach for Predicting TDCS Treatment Outcomes of Adolescents with Autism Spectrum Disorders
Official title: A Machine Learning Approach for Predicting TDCS Treatment Outcomes of Adolescents with Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Autistic Disorders Spectrum
Electroencephalography
Machine Learning
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2021-09-05
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behaviors. Particularly detrimental are the presence of restricted and 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.

Fundamental to these cognitive and behavioral problems is the disordered cortical connectivity and resultant executive dysfunction that underpin the use of effective strategies to integrate information across contexts. Brain connectivity problems affect the rate at which information travels across the brain. Slow processing speed relates to a reduced capacity of executive function to recall and formulate thoughts and actions automatically, with the result that autistic children with poor processing speed have great difficulty learning or perceiving relationships across multiple experiences. In consequence, these children compensate for the impaired ability to integrate information from the environment by memorizing visual details or individual rules from each situation. This explains why children with autism tend to follow routines in precise detail and show great distress over seemingly trivial changes in the environment.

To date, there is no known cure for ASD, and the disorder remains a highly disabling condition. Recently, a non-invasive brain stimulation technique, transcranial direct current Stimulation (tDCS) has shown great promise as a potentially effective and costeffective tool for reducing core symptoms such as anxiety, aggression, impulsivity, and inattention in patients with autism. This technique has been shown to modify behavior by inducing changes in cortical excitability and enhancing connectivity between the targeted brain areas. However, not all ASD patients respond to this intervention the same way and predicting the behavioral impact of tDCS in patients with ASD remains a clinical challenge. This proposed study thus aims to address these challenges by determining whether resting-state EEG and clinical data at baseline can be used to differentiate responders from non-responders to tDCS treatment. Findings from the study will provide new guidance for designing intervention programs for individuals with 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 intelligence quotient above 60.
* Individuals who demonstrate the ability to comprehend testing and stimulation instructions.

Exclusion Criteria:

* Individuals with severe motor dysfunctions that would hinder their participation, and those with history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study

Primary outcomes:
measure: Change in behavioral measures (social communication and restricted repetitive behavior) - Social Responsiveness Scale-2nd edition (SRS-2)
timeFrame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
Secondary outcomes:
measure: ASD symptomatology - The Autism Diagnostic Interview-Revised (ADI-R)
timeFrame: Day 1 of intervention (1 time point)
measure: Change in CANTAB® cognitive tests - Multitasking Test (MTT)
timeFrame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
measure: Change in CANTAB® cognitive tests - Stop Signal Task (SST)
timeFrame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
measure: Change in CANTAB® cognitive tests - Emotion Recognition Task (ERT)
timeFrame: Day 1 of intervention, and 1 day after the last day of intervention (2 time points)
measure: Change in Neurophysiological measures
timeFrame: Day 1 of intervention, and 1 day after the last day of intervention (2 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: