NCT07242625 A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
| NCT ID | NCT07242625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neudive Inc. |
| Condition | Attention-Deficit/Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-10-16 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Yoo-Sook Joung, MD, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT07242625 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Attention-Deficit/Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07242625 currently recruiting?
Yes, NCT07242625 is actively recruiting participants. Contact the research team at sungja_cho@neudive.com for enrollment information.
Where is the NCT07242625 trial being conducted?
This trial is being conducted at Daegu, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07242625 clinical trial?
NCT07242625 is sponsored by Neudive Inc.. The principal investigator is Yoo-Sook Joung, MD, PhD at Samsung Medical Center. The trial plans to enroll 48 participants.