Идёт набор NCT06880159

Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder

Без фазы С лечением Autism Spectrum Disorder (ASD) Transcranial Direct Current Stimulation (tDCS) Electroencephalography

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: tDCS with computerized cognitive training.
Кому может быть актуально: Состояния в реестре: Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS), Electroencephalography. Базовые параметры: 8 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Гонконг
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder

Обзор

Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD). Objective: (1) To assess the therapeutic effects of tDCS when combined with cognitive training for 10 consecutive weekdays on improving cognitive processing in children with ASD, relative to control group receiving sham-stimulation, and (2) to evaluate the associated neural mechanisms underlying the treatment effect of tDCS on children with ASD. Methods: To assess the therapeutic effects of tDCS, 90 adolescents with ASD (age 6-12 years) will be randomly assigned to active- (n=45), or sham- (n=45) tDCS groups. Twenty-minute sessions of tDCS stimulation to the left dorsolateral prefrontal cortex (DLPRC) will be provided on 10 consecutive weekdays, in conjunction with cognitive training exercises. Participants with a head circumference of less than 53 cm will receive 1.0 mA of stimulation, while those with a circumference of 53 cm or greater will receive 1.5 mA. EEG, fNIRS and neuropsychological tests will be administered before, immediately after, and 2 months after the series of tDCS sessions. Hypothesis: The investigators hypothesize that children with ASD who are randomly assigned to receive a montage of prefrontal tDCS, with cathode (inhibitory) placed over left DLPFC and anode (excitatory) over right supraorbital region) will evidence greater improvement in executive function (primary outcome) than children with ASD who are randomly assigned to receive sham-tDCS. In addition to testing the primary clinical outcome, stated above, in planned exploratory analyses, the investigators will also examine the effects of tDCS on secondary outcome measures of cognitive function, including information processing speed, working memory, inhibitory control, and cognitive flexibility; and conduct exploratory mediation analyses to better understand the potential neurophysiological factors underlying the therapeutic effects of tDCS. This will include E/I ratio as exploratory mediator variables. As these secondary analyses are exploratory, the investigators will report them as such in presentations and published papers, and the investigators will not draw definitive conclusions from them. Rather, they will be used to better understand the potential impact of tDCS and the mechanisms underlying impact, and to inform future research.

Вмешательства

Устройство tDCS with computerized cognitive training
Participants will complete tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. The training session will last for 20 minutes.

Первичные конечные точки

Average standardised score of executive function tests [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]

Вторичные конечные точки (6)

Change in CANTAB® cognitive test - Reaction Time (RTI) [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Change in CANTAB® cognitive test - Stop Signal Task (SST) [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Change in CANTAB® cognitive test - Multitasking Test (MTT): Response Latencies [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Change in CANTAB® cognitive test - Multitasking Test (MTT): Error Scores [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Change in CANTAB® cognitive test - Emotion Recognition Task (ERT) [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]
Change in Verbal Fluency Test (VFT) [Срок оценки: First day of intervention, 1 day and 2 months after the last day of intervention (3 time points, up to 2 months)]

Критерии участия

Критерии включения

being 8-12 years old
diagnosed with ASD given by registered psychiatrists or clinical psychologists according to the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) criteria of ASD
IQ score above 60
able to communicate in Chinese