None listed
Conditions
Interventions
Medical Device : Participants assigned to the intervention group will undergo an 8-week neurofeedback-based training program delivered via a smartphone application. The training will be performed at h
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants aged 8 to 15 years, inclusive. 2) Native Korean speakers. 3) Participants diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the Kiddie Schedule for Affective Disorders and Schizophrenia – Present and Lifetime Version (K-SADS-PL). 4) Participants with Verbal Comprehension Index (VCI) scores of 80 or above and Full-Scale IQ (FSIQ) scores of 70 or above on the Wechsler Intelligence Scale for Children – Fifth Edition (WISC-V). 5) Participants who are able to use a smartphone and have no difficulty using a mobile application. 6) Participants who, together with their parent(s) or legal guardian(s), have provided informed consent after receiving a full explanation of the study objectives and procedures. 7) For participants currently receiving pharmacological treatment for ADHD, there must have been no changes in the medication regimen (including active ingredient, formulation, dosage, or administration) during the one month prior to enrollment.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1) Participants diagnosed with a congenital genetic disorder. 2) Participants with a clear history of acquired brain injury, such as cerebral palsy. 3) Participants with a seizure disorder, other neurological disorders, or uncorrected sensory impairments. 4) Participants with a current or past history of schizophrenia or other childhood-onset psychotic disorders. 5) Participants with a Verbal Comprehension Index (VCI) score below 80 or a Full-Scale IQ (FSIQ) score below 70 on the Wechsler Intelligence Scale for Children – Fifth Edition (WISC-V). 6) Participants with comorbid obsessive-compulsive disorder (OCD), major depressive disorder (MDD), or bipolar disorder. 7) Participants with comorbid Tourette syndrome. 8) Participants with comorbid autism spectrum disorder (ASD) or other developmental disorders. 9) Participants with comorbid intellectual disability, language disorder, or severe learning disorder. 10) Participants with ophthalmologic conditions affecting eye gaze (e.g., strabismus). 11) Participants who have initiated non-pharmacological treatment within the past 3 months, or who are currently receiving non-pharmacological treatment for ADHD (e.g., cognitive behavioral therapy, neurofeedback, or working memory training). 12) Participants for whom changes in the dosage or administration of ADHD medication are anticipated during the clinical trial period. 13) Participants who, in the opinion of the investigator, are considered unsuitable for participation in the clinical trial for any other reason based on their medical condition or overall circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in K-ARS-5 score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in CGI-S score;Change in C-GAS score;Changes in Comprehensive Attention Test (CAT) parameters, including omission errors, commission errors, reaction time, and reaction time standard deviation for each attention subdomain.;Change in SCWT score;Change in CCTT score;Change in BRIEF score;Change in TBR score;Incidence of adverse events(AEs) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung-Ah Lee
Seoul National University Hospital
Outcome results
None listed