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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.
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).
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.
[Safety Evaluation] Safety was assessed throughout the study period by monitoring adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The treatment group used the device with driving and N-BACK cognitive training functions. | Experimental | The 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. |
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| The control group used a device that included only the driving function, without the N-BACK cognitiv | Sham Comparator | The 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model Name: EMT-SR01;red | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emotiv | Seoul | gangnam | 06179 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42204362 | Derived | 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. doi: 10.1038/s41746-026-02721-3. Online ahead of print. |
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| 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. |
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| 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. |
| 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. | 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. |
| 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. | 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. |
| 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:
| 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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