NCT07242625

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Neudive Inc. · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Attention-Deficit/Hyperactivity Disorder
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	TAU	TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.

Timeline

• Start date: 2025-10-16
• Primary completion: 2026-04-01
• Completion: 2026-08-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

3 sites across 1 country: South Korea