Health Trials

About this trial

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 criteria

Qualifiers

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

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

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • NDTx-02 + TAU
  • TAU

Treatment groups

48 Participants
are divided into 2 treatment groups

Locations

3
Daegu Catholic University Medical Center42472, Daegu South Korea
Samsung Medical Center06351, Seoul South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital06591, Seoul South Korea

Sponsors and collaborators

Neudive Inc.

Lead sponsor

Source ClinicalTrials.gov