Digital Therapy NDTx-02 for Executive Function in Children With ADHD or Autism
Tests the digital therapy NDTx-02 in children with ADHD or autism.
Plain-language title generated from the registry record
Registry title: A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Key facts
- Where
- Daegu and Seoul, South KoreaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 12 years old?
Source: NCT07242625, who can take part
Where in South Korea
- Daegu Catholic University Medical CenterDaegu, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- The Catholic University of Korea, Seoul ST. Mary's HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neudive Inc.
- Trial code
- NCT07242625
- Record updated
- 21 November 2025
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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.
Exclusion: Serious trauma or surgery performed within 4 weeks before the screening date; 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; Severe acute/chronic medical or mental illness; Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.); 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; 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.