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ADHD - Attention Deficit Disorder With HyperactivityNCT07173439

Multi-center, Single Blinded, RCT, Pivotal Study to Evaluate the Efficacy and Safety of DTx to Improve ADHD

A study testing Model Name: EMT-SR01;red in people with ADHD - Attention Deficit Disorder With Hyperactivity and ADHD - Combined Type, run by EMOTIV at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, impulsivity, and impaired executive functioning. It typically begins in childhood and is often first diagnosed at school age due to learning and social behavioral difficulties. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
Model Name: EMT-SR01;red
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSouth Korea
Study dates
15 Apr 2024to 13 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Subjects must meet all the following inclusion criteria:
  • Children and adolescents aged 6 years or older but under 13 years, both male and female.
  • Diagnosed with ADHD according to DSM-5 criteria or ICD-10 diagnosis of ADHD (F90.0).
  • K-ARS scores of 18 or higher for females and 22 or higher for males.
  • No changes in ADHD medication dosage or regimen within 1 month prior to enrollment (*For those receiving pharmacological treatment with methylphenidate or amphetamine-based products, a washout period of 14 days is required if they wish to participate after discontinuing medication).
  • Medically healthy based on medical history and vital signs assessed during screening, without other medical abnormalities.
  • Able to use a smartphone or tablet PC that meets specified requirements to operate the mobile application without difficulty.
  • Both the subject and their guardian voluntarily agree to participate and provide written informed consent.

Who cannot join

  • Subjects will be excluded if they meet any of the following criteria:
  • Presence of any of the following psychiatric symptoms at baseline: chronic tic disorder (requiring medication), Tourette's disorder, or history of major obsessive-compulsive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder, conduct disorder, or other childhood psychosis (affective disorders are not exclusionary).
  • Wechsler Intelligence Scale for Children (WISC) score below 80.
  • Presence of congenital genetic disorders.
  • Uncontrolled or severe systemic physical illness requiring hospitalization at baseline.
  • Suicide attempt within the past 3 months and assessed as high suicide risk by a psychiatrist.
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  • Initiation or ongoing other cognitive behavioral therapy within the past 3 months (including any CBT for ADHD or other conditions, based on insurance coverage).
  • Presence of visual, auditory, or cognitive impairments.
  • Any other reasons deemed by the investigator to make the subject unsuitable for participation in the clinical trial.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Emotiv

    Seoul, gangnam, 06179

Other trials in South Korea

About this study

Official title: A Multi-center, Prospective, Single Blinded, Randomized, Comparative, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Digital Therapeutics to Improve ADHD Symptoms of Patients Diagnosed With ADHD

Background:

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, impulsivity, and impaired executive functioning. It typically begins in childhood and is often first diagnosed at school age due to learning and social behavioral difficulties. Therefore, ADHD treatment aims to directly enhance attention, reduce hyperactivity and impulsivity, and ultimately improve task performance and associated behavioral and relational issues.

Read more

Objective of the Clinical Trial:

To evaluate the safety of the investigational digital therapeutic device for the treatment of ADHD.

To evaluate the efficacy of the investigational digital therapeutic device for the treatment of ADHD.

Study Design \& Methodology:

A total of 122 participants were enrolled (62 in the treatment group and 60 in the control group), with 114 participants included in the Full Analysis Set (FAS: 58 treatment, 56 control).

Read the detailed description

Expanded Clinical Summary: Investigational Digital Therapeutic Device for ADHD

[Background and Rationale] Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by a persistent pattern of inattention, hyperactivity, impulsivity, and impairments in executive function. These symptoms typically begin in childhood and are often first identified in school-aged children due to learning difficulties or social behavioral issues.

Effective treatment of ADHD aims to improve sustained attention, reduce hyperactivity and impulsivity, and enhance the patient's ability to engage in academic, social, and daily life activities. While pharmacological interventions have been the mainstay of treatment, increasing attention has been directed toward non-pharmacologic and digital therapeutic approaches, particularly those that can target cognitive mechanisms such as executive functioning through neuroplasticity-enhancing modalities.

[Objectives of the Clinical Trial]

The aim of this clinical investigation was twofold:

To assess the safety of the investigational digital therapeutic (DTx) device when used by children diagnosed with ADHD.

To evaluate the efficacy of the DTx in improving core symptoms of ADHD compared to a sham (placebo) digital intervention.

[Study Design and Methodology] This was a prospective, multi-center, single-blind, randomized controlled confirmatory trial involving two arms: an experimental group receiving the active digital therapeutic intervention and a control group receiving a digital sham.

The investigational DTx is a game-based software intervention designed to train cognitive flexibility, working memory, and inhibitory control - core executive functions associated with ADHD - through repetitive and engaging digital activities.

-Primary Outcomes: ADHD-RS (Investigator-Rated Scale)

-Secondary Outcomes: Additional cognitive and behavioral endpoints further supported the efficacy of the intervention.

  • Parent-rated ADHD-RS-IV (Korean ADHD Rating Scale, K-ARS)
  • Stroop Color-Word Interference Test (color-word score)
  • Advanced Test of Attention (ATA), visual sensitivity score
  • CGI-S(Clinical Global Impression-Severity)
  • CGI-I(Clinical Global Impression-Improvement)
  • CCTT(Children's Color Trails Test)
  • K-CPRS(Korean-Conners Parents Rating Scale)
  • WCST(Wisconsin Card Sorting Test)
  • Changes in Medication Dosage
  • Patient-Reported Outcomes

[Safety Evaluation] Safety was assessed throughout the study period by monitoring adverse events.

Being tested
Model Name: EMT-SR01;red, Model Name: EMT-SR01;red (Placebo)
Keywords
ADHD, DTx
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Model Name: EMT-SR01;redDevice

    The investigational device incorporated both a driving simulation and an N-Back cognitive training function. These features were designed to engage and improve key cognitive abilities such as attention, working memory, and executive function, which are often impaired in individuals with ADHD. The combined use of driving tasks and N-Back exercises aimed to provide a comprehensive and interactive therapeutic intervention to reduce core ADHD symptoms.

  • Model Name: EMT-SR01;red (Placebo)Device

    The placebo device incorporated only the driving simulation function and excluded the N-Back cognitive training component. The driving simulation was designed as a sham intervention to mimic the user experience without providing the active therapeutic elements targeting cognitive functions. This setup enabled a controlled comparison with the active digital therapeutic device.

Study groups in NCT07173439
Study groupRoleWhat they receive
The treatment group used the device with driving and N-BACK cognitive training functions.ExperimentalThe treatment group participated in the clinical trial by using the investigational digital therapeutic device, which incorporated both driving simulation and N-BACK cognitive training functions. These features were designed to engage and improve key cognitive abilities such as attention, working memory, and executive function, which are often impaired in individuals with ADHD. The combined use of driving tasks and N-BACK exercises aimed to provide a comprehensive and interactive therapeutic intervention to help reduce core ADHD symptoms.
Receives: Device: Model Name: EMT-SR01;red
The control group used a device that included only the driving function, without the N-BACK cognitivSham comparatorThe control group participated in the clinical trial using a digital device that incorporated only the driving simulation function. Unlike the treatment group, this device did not include the N-BACK cognitive training component. The driving function served as a digital placebo (sham) intervention designed to mimic the user experience without providing the active therapeutic elements targeting cognitive functions. This setup allowed for a controlled comparison to evaluate the efficacy of the combined intervention in the treatment group.
Receives: Device: Model Name: EMT-SR01;red (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS)

    The Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS, Investigator-Rated) is a clinician-administered assessment tool based on the DSM-IV diagnostic criteria for ADHD.

    It includes 18 items, with 9 items assessing inattention and 9 items assessing hyperactivity/impulsivity.

    Each item is scored on a 4-point scale (0 = never or rarely, 3 = very often).

    The total score reflects overall ADHD symptom severity, with higher scores indicating greater severity.

    The investigator-rated version is completed by a trained clinician through interviews and behavioral observations, rather than by parents or teachers.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

Secondary outcomes (7)

  1. ADHD-RS-IV (Parent-rated, Korean version)

    The Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV, Parent-rated, Korean version) is a standardized rating scale based on the DSM-IV diagnostic criteria for ADHD.

    It consists of 18 items corresponding to the inattention (9 items) and hyperactivity/impulsivity (9 items) symptom domains.

    Parents rate the frequency of each symptom on a 4-point Likert scale ranging from 0 (never or rarely) to 3 (very often).

    The Korean version has been translated and validated for use in Korean populations.

    Higher scores indicate greater severity of ADHD symptoms.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

  2. CGI-S(Clinical Global Impression-Severity)

    The Clinical Global Impression - Severity (CGI-S) scale is a 7-point clinician-rated scale that assesses the clinician's global impression of the patient's current illness severity at the time of evaluation.

    The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

    It provides a simple, standardized measure of overall illness severity, independent of specific symptom rating scales.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

  3. CGI-I(Clinical Global Impression-Improvement)

    The Clinical Global Impression - Improvement (CGI-I) scale is a 7-point clinician-rated scale used to assess how much a patient's illness has improved or worsened relative to baseline.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

  4. CCTT(Children's Color Trails Test)

    The Children's Color Trails Test (CCTT) is a neuropsychological assessment tool designed to evaluate cognitive functions in children, particularly:

    • Attention and sustained focus
    • Cognitive flexibility (set-shifting, task-switching)
    • Processing speed
    • Executive functioning

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

  5. Stroop

    The Stroop Test (Stroop Color and Word Test) is a widely used neuropsychological assessment designed to measure attention, selective attention, processing speed, and inhibitory control, which are key aspects of executive function.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

  6. Changes in Medication Dosage

    Changes in Medication Dosage refers to any adjustments in the dose of a participant's prescribed ADHD medication during the study period.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

  7. Patient-Centered Outcomes

    Satisfaction (10-point)

    Participants will rate their overall satisfaction with the intervention on a 10-point Visual Analog Scale (VAS), with higher scores indicating greater satisfaction.

    Task Difficulty (10-point)

    Participants will rate the perceived difficulty of the tasks on a 10-point VAS, with higher scores indicating greater difficulty.

    Suggestions for Improvement (Open-ended)

    Participants can provide subjective comments or suggestions regarding the intervention.

    Willingness to Pay (Objective)

    Participants will indicate their willingness to pay for the intervention using a structured, objective questionnaire.

    Measured: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start15 Apr 2024
  3. Primary completion13 May 2025
  4. Study completion13 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07173439
Sponsor's protocol ID
EM_SNU_001
Status last verified
Aug 2025
First submitted
20 Aug 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee S, Lim YB, Choi W, Park S, Han BR, Lee S, Lee S, Lim YK, Lim S, Chung EJ, Kang D, Son I, Min J, Kim JI, Kim BN. Multicenter randomized trial of a digital therapeutic game for executive function in children with ADHD. NPJ Digit Med. 2026 May 27;9(1):645. doi: 10.1038/s41746-026-02721-3.

    PubMed 42204362

Questions about this trial

What is this clinical trial studying?

A study testing Model Name: EMT-SR01;red in people with ADHD - Attention Deficit Disorder With Hyperactivity and ADHD - Combined Type, run by EMOTIV at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS) (time frame: The digital therapy was administered over 4 weeks, including 6-7 visits (2-3 onsite, 4 phone). Screening and Baseline visits could occur on the same day. Final follow-up took place at week 4 post-treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07173439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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