Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents

Официальное название

Cumulative and Booster Effects of Multisession Prefrontal tDCS on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder

Обзор

Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD.

Вмешательства

• Устройство Active-tDCS
  For active-tDCS condition, participants will receive stimulation on the dorsolateral prefrontal cortex with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds. Following that, a twenty-minute executive functional training task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the training task ends.
• Устройство Sham-tDCS
  For sham-tDCS condition, participants will receive initial stimulation with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp then it will be discontinued. Participants will also receive the twenty-minute executive functional training task five minutes subsequent to the stimulation mode.

Первичные конечные точки

• Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) [Срок оценки: Phase 1 (RCT): Week 0, week 2, week 4, and week 6 of the study (4 time points); Phase 2 (crossover): Week 0 and week 2 (2 time points); Phase 3 (follow-up): Week 6, 10, 14, 18, 22, 26 (6 time points)]

Вторичные конечные точки (2)

• Clinical response in tDCS outcome [Срок оценки: Phase 1 (RCT): Week 0, week 2, week 4, and week 6 of the study (4 time points); Phase 2 (crossover): Week 0 and week 2 (2 time points)]
• Change in neuropsychological measures - CANTAB® cognitive tests [Срок оценки: Phase 1 (RCT): Week 0, week 2, week 4, and week 6 of the study (4 time points); Phase 2 (crossover): Week 0 and week 2 (2 time points); Phase 3 (follow-up): Week 6, 10, 14, 18, 22, 26 (6 time points)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Hung Hom

Идентификаторы

NCT: NCT06272669 · HSEARS20220216004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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