NCT07173439

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: EMOTIV · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Model Name: EMT-SR01;red	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.
DEVICE	Model Name: EMT-SR01;red (Placebo)	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.

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-05-13
• Completion: 2025-05-13
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: South Korea