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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS)
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
The treatment group used the device with driving and N-BACK cognitive training functions.
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.
干预措施: Model Name: EMT-SR01;red (Device)
The control group used a device that included only the driving function, without the N-BACK cognitiv
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.
干预措施: Model Name: EMT-SR01;red (Placebo) (Device)
结局指标
主要结局
Change from baseline in ADHD-RS (Investigator-Rated Scale) at end of treatment (FAS)
时间窗: 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.
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.
次要结局
- 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.)
- Changes in Medication Dosage(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(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.)