Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
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: trans cranial direct current stimulation (tDCS), Sham.
- Кому может быть актуально
- Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 5 лет — 21 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
- США
- 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
Right Lateralized Posterior Cerebellar tDCS in Children With Autism Spectrum Disorder
Обзор
The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).
Подробное описание
The study will be randomized, double-blind, within subject crossover design. It will involve a group of 30-40 children and young adults with Autism Spectrum Disorder (ASD). We may recruit up to 60 subjects. Diagnosis of ASD will be confirmed with the Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule-2 (ADOS-2) by a research-reliable clinician. Each participant will undergo a sham condition and a transcranial direct current stimulation (tDCS) condition, the order of sham and tDCS conditions will be randomly assigned to each participant during baseline testing. Sham refers to participants only receiving 1 milliamp of tDCS stimulation for 1 minute, and tDCS stimulation refers to 20 minutes of tDCS stimulation. The study involves an initial screening visit followed by two sessions with three months between each session period. Each session includes the following: pre-testing and imaging, tDCS 3-week session, post-testing and imaging. Participants will complete an initial screening to confirm clinical diagnosis of ASD, determine baseline cognitive functioning, and complete a practice Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) session. At pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an MRI and/or MEG. Each 3-week tDCS sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation. Neither the researchers nor the participants will know which group they are assigned during each three-week session.
Вмешательства
- Устройство trans cranial direct current stimulation (tDCS)
Three weeks of 20-minute tDCS stimulation - Устройство Sham
Three weeks of sham stimulation
Первичные конечные точки
- Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version [Срок оценки: Baseline]
- Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version [Срок оценки: Post Treatment (approx at 3 month)]
- Social behavior as measured by Cyberball/Social Ball Throwing Task [Срок оценки: Baseline]
- Social behavior as measured by Cyberball/Social Ball Throwing Task [Срок оценки: Post Treatment (approx at 3 month)]
- Sensorimotor behavior as measured by Grip Strength [Срок оценки: Baseline]
- Sensorimotor behavior as measured by Grip Strength [Срок оценки: Post Treatment (approx at 3 month)]
- Sensorimotor behavior as measured by Reach Task [Срок оценки: Baseline]
- Sensorimotor behavior as measured by Reach Task [Срок оценки: Post Treatment (approx at 3 month)]
- Sensorimotor behavior as measured by Sensory Profile-2 [Срок оценки: Baseline]
- Sensorimotor behavior as measured by Sensory Profile-2 [Срок оценки: Post Treatment (approx at 3 month)]
Вторичные конечные точки (6)
- Executive functioning as measured by Flanker Inhibitory Control and Attention [Срок оценки: Baseline]
- Executive functioning as measured by Flanker Inhibitory Control and Attention [Срок оценки: Post Treatment (approx at 3 month)]
- Executive functioning as measured by Dimensional Card Change Sort [Срок оценки: Baseline]
- Executive functioning as measured by Dimensional Card Change Sort [Срок оценки: Post Treatment (approx at 3 month)]
- Working memory as measured by Stanford Binet-V Working Memory Subtest [Срок оценки: Baseline]
- Working memory as measured by Stanford Binet-V Working Memory Subtest [Срок оценки: Post Treatment (approx at 3 month)]
Критерии участия
Критерии включения
- Ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician
Критерии исключения
- Pregnancy
- Brain implants
- Pacemakers
- Any biomedical or metal implants in any part of body
- Hearing or visual impairment
- History of brain injury
- Known brain or skull abnormality other than those that may be associated with ASD
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- UT Southwestern Medical Center — Dalls
Идентификаторы
NCT: NCT05691283 · STU-2022-0689