Actively Recruiting
A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Led by Neudive Inc. · Updated on 2025-11-21
48
Participants Needed
3
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 ADI-R or ADOS, 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 assistance
- Able to comply with the recommended schedule of 30 sessions over 6 weeks
- Agree to not add or change any treatment/education/rehabilitation or medications during the study, except continuation of pre-existing TAU
- Participant and parent or legal guardian voluntarily consent to join the trial
- Willing to comply with clinical trial procedures
You will not qualify if you...
- Risk of significant behavioral, emotional, psychotic symptoms, self-harm, or other harm affecting treatment
- Severe acute or chronic medical or mental illness
- Serious trauma or surgery within 4 weeks before screening
- Severe neurological diseases or other disabilities
- Participation in another clinical trial within 30 days before screening
- Medication changes affecting cognitive function within 4 weeks before baseline
- Changes in treatment/education/rehabilitation programs affecting cognitive function within 4 weeks before baseline
- Prior use of cognitive improvement or daily living improvement software within 12 weeks before baseline
- Investigator judgment that participation is inappropriate due to ethical reasons or result influence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Daegu Catholic University Medical Center
Daegu, South Korea, 42472
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
3
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
Research Team
S
SungJa Cho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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