A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD

Официальное название

A Multi-center, Prospective, Compared, Randomized, Evaluator-blinded, Pilot Study to Evaluate the Effectiveness of Digital Therapeutics 'NDTx-02' on Executive Function in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)

Обзор

The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD).

Подробное описание

This pilot clinical trial aims to evaluate the preliminary safety and effectiveness of NDTx-02 in combination with Treatment-As-Usual (TAU) compared with TAU alone (waitlist control).

The study will employ a randomized waitlist-control design, in which participants will be assigned to either experimental group (immediate intervention) or waitlist control group (delayed intervention) with a 1:1 ratio.

* Experimental group (immediate intervention): NDTx-02 + TAU for the first 6 weeks (stage 1), followed by TAU only for the following 6 weeks (stage 2). * Waitlist control group (delayed intervention): TAU only during the first 6 weeks (stage 1), followed by NDTx-02 + TAU for the following 6 weeks (stage 2).

Efficacy will be assessed using the K-BRIEF-2, K-VABS-II, K-ARS-5, KAT, WMT, C-TMT, Stroop Color and Word Test Children's Version, Digit Span test, CGI-S, and CGI-I.

The primary efficacy analysis will compare the experimental group and the waitlist control group during Stage 1 (weeks 0-6). The delayed intervention period (Stage 2) will be analyzed as secondary/exploratory.

Вмешательства

• Устройство NDTx-02 + TAU
  NDTx-02 intervention: Participants will be provided with a tablet pre-installed with NDTx-02 and instructed to use the device five times per week for six weeks, for a total of 30 sessions.
• Поведенческое TAU
  TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.

Первичные конечные точки

• K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]

Вторичные конечные точки (9)

• K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• K-VABS-II (Korean Vineland Adaptive Behavior Scales-II) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• KAT (Korean Attention Test System) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• WMT (Working Memory Test for Children) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• C-TMT (Color Trail Making Test for Children) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• Stroop Color and Word Test - Children's Version [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• Digit Span Test [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• CGI-S (Clinical Global Impression-Severity) [Срок оценки: Baseline (V2,V4), Day 42 (V4,V6)]
• CGI-I (Clinical Global Impression-Improvement) [Срок оценки: Day 42 (V4,V6)]

Критерии участия

Критерии включения

• Children and adolescents aged 5 to 12 years at the time of screening
• Diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)\* by a psychiatrist according to DSM-5 diagnostic criteria

\*For ASD, diagnosis can be supported by the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule (ADOS), either version 1 or 2

• Full-Scale Intelligence Quotient (FSIQ) of 65 or higher
• Able to use the 'NDTx-02' installed on a tablet, alone or with the assistance of a guardian
• Able to comply with the recommended application schedule for the investigational device (6 weeks, 30 sessions, 5 times per week)
• Agree not to add or change any treatment/education/rehabilitation programs or medications, including Applied Behavior Analysis (ABA) or cognitive therapy, during the study period (continuation of pre-existing TAU \[Treatment-As-Usual\] is allowed)
• Participant and parent (or legal guardian) voluntarily decide to join the trial and provide written informed consent
• Participants willing to comply with the clinical trial procedures

Критерии исключения

• A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
• Severe acute/chronic medical or mental illness
• Serious trauma or surgery performed within 4 weeks before the screening date
• Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
• Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
• Change in the dosage or regimen of medications that may significantly affect cognitive function within 4 weeks prior to the baseline visit
• Change in participation in treatment/education/rehabilitation programs that may significantly affect cognitive function within 4 weeks prior to the baseline visit
• Participation in a clinical trial of, or prior experience using, cognitive improvement or daily living improvement software within 12 weeks prior to the baseline visit
• In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial

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

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 3 центра

• Daegu Catholic University Medical Center — Daegu
• Samsung Medical Center — Seoul
• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul

Идентификаторы

NCT: NCT07242625 · ND-05 · DIP2024BrainAI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗