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Идёт набор NCT06950437

pBFS Guided aiTBS Over Language Network for ASD Child

Без фазы С лечением Autism Spectrum Disorder Language Delay

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: active iTBS, Sham iTBS, speech therapy.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Language Delay. Базовые параметры: 3 лет — 6 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
Китай
Следующий шаг
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Официальное название

Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Language Deficit Comorbid in Autism Spectrum Disorder Child: a Multi-center, Randomized, Sham-controlled Trial

Обзор

The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.

Подробное описание

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder often accompanied by language delay. Emerging evidence indicates that Transcranial Magnetic Stimulation (TMS) has been effective in restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown.

By leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can accurately locate the individual language function brain network. Considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (SFG) for 12 weeks.

In this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 iTBS sessions over the SFG per day. The inter-session interval is set at 50 minutes, along with speech therapy. Clinical evaluations focusing on language and ASD symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of treatment.

Вмешательства

  • Устройство active iTBS
    Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.
  • Устройство Sham iTBS
    Participants will undergo three sham iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.
  • Поведенческое speech therapy
    Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.

Первичные конечные точки

  • CLAS-TP score change after treatment [Срок оценки: Pre-treatment (baseline), post-treatment (12-week)]
Вторичные конечные точки (4)
  • CLAS-TP total score change from baseline to follow-up [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
  • CLAS-TP subscale score change from baseline to follow-up [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
  • WPPSI language score change from baseline to follow-up [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]
  • ADOS-2 SA score change from baseline to follow-up [Срок оценки: Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)]

Критерии участия

Критерии включения

  • Professionally diagnosed with ASD per DSM - 5 criteria.
  • Aged 3 - 6.5 years, either gender.
  • ADOS-2 results meet ASD standard cut - off.
  • SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age < 4 years).
  • Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age > 18 months; any CLAS-TP dimension score < 6.
  • Mandarin is the daily communication language.
  • May have intellectual/global developmental delay not explaining ASD symptoms.
  • Guardians volunteer, can cooperate in treatment and sign informed consent.

Критерии исключения

  • Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
  • Serious self-harm in the past year.
  • Severe sensory/motor disorders precluding cooperation.
  • History of epileptic seizures.
  • Serious organic diseases, especially brain related.
  • Contraindications for MRI/TMS (metal/implants).
  • Respiratory/circulatory diseases with sedation risk.
  • Illiterate guardians unable to handle informed consent/questionnaires.
  • Received neuromodulation in the past 3 months.
  • Currently in other clinical trials.
  • Deemed unfit by the researcher.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University Sixth Hospital — Пекин

Идентификаторы

NCT: NCT06950437 · NGASD002DMC_150

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗