RecruitingNot ApplicableNCT07242625

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)

Sponsor

Neudive Inc.

Enrollment

48 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder

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).

Eligibility

Min Age: 5 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called NDTx-02 + TAU and a behavioral approach called TAU for people with attention deficit hyperactivity disorder and autism spectrum disorder. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 5 Years to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENDTx-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.

BEHAVIORALTAU

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