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

NCT07242625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-11-21

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Neudive Inc.

    lead INDUSTRY

Principal Investigators

  • Yoo-Sook Joung, MD, PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2026-04-30
Completion
2026-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242625 on ClinicalTrials.gov