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Can a video game boost brain power in kids with ADHD or autism?

NCT ID NCT07242625

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a digital therapy called NDTx-02, designed to help children aged 5 to 12 with ADHD or autism improve their executive function—skills like planning, focus, and self-control. The study will involve 48 participants and compare the digital therapy to standard care. The goal is to see if this game-like treatment is safe and can ease daily challenges without medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Daegu Catholic University Medical Center

    RECRUITING

    Daegu, 42472, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

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Other studies related to the condition(s) this trial covers.