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

NCT07173439 | Completed

• 1 other identifier: EM_SNU_001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity; ADHD - Combined Type; ADHD

Keywords

ADHD; DTx

Outcome Measures

Primary Outcomes (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.

  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)

• ADHD-RS-IV (Parent-rated, Korean version)

  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 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 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 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 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.

Study Arms (2)

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.

Device: Model Name: EMT-SR01;red

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.

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

Interventions

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.

The treatment group used the device with driving and N-BACK cognitive training functions.

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.

The control group used a device that included only the driving function, without the N-BACK cognitiv

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subjects will be excluded if they meet any of the following criteria:
• 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.
• 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.

Sponsors & Collaborators

• EMOTIV: lead

Study Sites (1)

Emotiv

Seoul, gangnam, 06179, South Korea

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 15, 2025
• Study Start: April 15, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)