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Идёт набор NCT06369714

Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.

Без фазы С лечением Attention Deficit Disorder With Hyperactivity Executive Function Disorder

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: Concerta, Digital therapeutics.
Кому может быть актуально
Состояния в реестре: Attention Deficit Disorder With Hyperactivity, Executive Function Disorder. Базовые параметры: 6 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
Китай
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

Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.

Обзор

A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.

Вмешательства

  • Препарат Concerta
    Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
  • Устройство Digital therapeutics
    30 sessions of digital therapeutics, each lasting 30 minutes, will be conducted with a frequency of once every 1-2 days over an 8-week period.

Первичные конечные точки

  • Swanson, Nolan, and Pelham IV Rating Scale [Срок оценки: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
Вторичные конечные точки (5)
  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD [Срок оценки: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
  • Questionnaire-Children with Difficulties [Срок оценки: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
  • Behavior Rating Inventory of Executive Function [Срок оценки: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
  • Continuous Performance Test [Срок оценки: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
  • Digital Cancellation Test [Срок оценки: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]

Критерии участия

Критерии включения

  • Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.
  • Digital Cancellation Test total score<50 points.
  • Raven's Standard Progressive Matrices score≥85.
  • 6 years ≤ Age<12 years.
  • No interventions for ADHD received within 4 weeks.
  • No color blindness.

Критерии исключения

  • Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.
  • Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.
  • Patients with comorbid conduct disorders.
  • Patients with severe traumatic brain injury or neurological disorders.
  • Patients with a history of severe somatic diseases.
  • Patients with a history of substance or drug dependency.

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Changzheng Hospital, Naval Medical University — Шанхай
  • Changhai Hospital, Naval Medical University — Шанхай

Публикации

  • Zhao X, Cai Y, Zhang X, Xu T, Qian Y, Hao W, Wang Y, Yuan J, Cai T, Zhou L, Li H, Lei L. Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial. Trials. 2026 May 18;27(1):484. doi: 10.1186/s13063-026-09775-4. PMID 42152117

Идентификаторы

NCT: NCT06369714 · CHEC2023-296

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗