Идёт набор NCT06878326

Resting-State Functional Connectivity as a Predictor of tDCS Effects in Adolescents 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.
Кому может быть актуально: Состояния в реестре: Autism Spectrum Disorder (ASD), Transcranial Direct Current Stimulation (tDCS), Electroencephalography. Базовые параметры: 12 лет — 22 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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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 evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD, (2) to better understand the neural mechanisms underlying the neuromodulation effects of tDCS in patients with ASD, and (3) to determine whether resting-state functional connectivity measures can predict the therapeutic effects of active tDCS in individuals with ASD. Methods: To assess the therapeutic effects and neural mechanisms of tDCS, 90 adolescents with ASD (age 12-22 years) will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS with at least a week apart each time. During the active tDCS or sham-tDCS condition, the participants will be administered a computerized test battery (Cambridge Neuropsychological Test Automated Battery, CANTAB®) to evaluate their cognitive function. EEG before and after the tDCS to evaluate the tDCS-induced alteration in their neural activity and functional connectivity. Hypothesis: Drawing together the different evidence linking ASD with cortical hyper-excitability and disordered neural connectivity, as reviewed previously, the investigators hypothesize that, relative to a sham-tDCS condition, active cathodal (inhibitory) and anodal (excitatory) tDCS over the left DLPRC will induce stimulation-linked facilitation of learning and resultant improvement of cognitive functioning in patients with ASD. In addition to the therapeutic effects of tDCS, enhanced neural connectivity, as indexed by altered level EEG theta coherence in patients with ASD, will mediate the beneficial effects of tDCS, relative to sham tDCS, on improvements in cognitive function. Moreover, resting-state functional connectivity will moderate the beneficial effects of active tDCS on cognitive function, relative to sham tDCS, such that participants with greater pre-treatment resting state functional connectively will evidence greater/less response to tDCS, relative to participants receiving sham tDCS.

Вмешательства

Устройство tDCS
Participant will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS. The order of the conditions will be randomized and counterbalanced across participants, and the three stimulation conditions will be administered at least a week apart to avoid carry-over effects. The tDCS session will last for 20 minutes.

Первичные конечные точки

Change in CANTAB® cognitive test - Reaction Time (RTI) [Срок оценки: During each stimulation session, last around 3mins]
Change in CANTAB® cognitive test - Spatial Working Memory (SWM) [Срок оценки: During each stimulation session, last around 6mins]
Change in CANTAB® cognitive test - Multitasking Test (MTT): Response Latencies [Срок оценки: During each stimulation session, last around 8mins]
Change in CANTAB® cognitive test - Multitasking Test (MTT): Error Scores [Срок оценки: During each stimulation session, last around 8mins]
Changes in EEG theta coherence [Срок оценки: Before tDCS session, Right after tDCS session (2 timepoints, up to 20 minutes)]

Критерии участия

Критерии включения

being 12-22 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
able to communicate in Chinese