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

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.

• 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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.