A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Recruiting · NCT07242625 · Interventional (participants receive a specific treatment) · Lead sponsor: Neudive Inc.
View the official record on ClinicalTrials.gov →Interventions studied
NDTx-02 + TAUTAU
What this trial is about
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).
Who can take part
Age range
5 Years to 12 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.)
- 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
- 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
Where it is running
3 locations listed.
- Daegu Catholic University Medical Center - Daegu, South Korea
- Samsung Medical Center - Seoul, South Korea
- The Catholic University of Korea, Seoul St. Mary's Hospital - Seoul, South Korea