None listed
Conditions
Interventions
Medical Device : This medical device is a digital therapeutic device for Attention-Deficit/Hyperactivity Disorder (ADHD), delivered in the form of a gamified software application. It can be used by in
Sponsors
Dragonfly GF Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female children and adolescents aged 7 years or older and under 13 years 2) Children and adolescents who have been diagnosed with ADHD by a psychiatrist and are currently taking ADHD medication 3) Children and adolescents whose ADHD medication dosage and administration regimen have remained unchanged within the past month 4) Individuals deemed medically healthy based on medical history and vital signs assessed during the screening visit 5) Individuals who voluntarily decide to participate in this clinical trial with their legal guardian and provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Individuals with an IQ below 70 on a standardized intelligence test 2) Individuals with congenital genetic disorders 3) Individuals with a clear history of acquired brain injury such as cerebral palsy 4) Individuals with a history of schizophrenia, bipolar disorder, or other childhood psychoses 5) Individuals with seizure disorders, other neurological conditions, or uncorrected sensory impairments 6) Individuals deemed to have serious suicidal ideation 7) Individuals with serious medical conditions (e.g., cardiovascular, hepatic, renal, respiratory diseases, or glaucoma) 8) Individuals who participated in another interventional clinical trial within 30 days prior to screening 9) Individuals who are unable to communicate or follow instructions 10) Any individual otherwise deemed by the investigator to be unsuitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Advanced Test of Attention (ATA) at Week 4 following initial application of the investigational medical device;Change from baseline in Korean version of ADHD Rating Scale(K-ARS) at Week 4 following initial application of the investigational medical device | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Clinical Global Impression-Severity at Week 4 following initial application of the investigational medical device;Clinical Global Impression-Improvement at Week 4 following initial application of the investigational medical device;Change from baseline in quantitative Electroencephalogram(qEEG) following initial application of the investigational medical device;Change from baseline in functional Near-Infrared Spectroscopy(fNIRS) following initial application of the investigational medical device | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungheon Yang
Daegu Catholic University Medical Center
Outcome results
None listed