None listed
Conditions
Sponsors
InTheTech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged 6 to 12 years. 2. Individuals with a documented diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), or the International Classification of Diseases, 10th Revision (ICD-10), at the time of screening. 3. Individuals with an IQ score of 80 or higher on the Korean version of the Wechsler Intelligence Scale for Children – Fifth Edition (K-WISC-V) at baseline. 4. Individuals who have been stably receiving ADHD medication for at least 12 weeks prior to baseline. 5. Individuals who have a parent or legal representative available to support them throughout the clinical trial. *The legal representative is defined as a parent or guardian who can decide on the child’s participation, assist with the use of the investigational medical device, and report the child’s condition. 6. Individuals (and/or their parent or legal representative) who voluntarily agree to participate in the clinical trial and provide written informed consent after receiving a full explanation. 7. Individuals who are willing and able to comply with the clinical trial protocol. 8. Individuals who, at the time of enrollment, meet all eligibility criteria as outlined in the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals who, at the time of screening, are diagnosed with one or more of the following psychiatric disorders in addition to ADHD: ? Severe obsessive-compulsive disorder ? Schizophrenia ? Bipolar disorder ? Autism spectrum disorder ? Epilepsy or other neurological disorders ? Severe depression ? Other conditions deemed inappropriate for clinical trial participation by the investigator 2. Individuals with physical conditions that may interfere with the use of the investigational medical device during the clinical trial (e.g., color blindness, strabismus, physical deformities of the hands or arms, etc.) 3. Individuals who meet one or more of the following criteria regarding ADHD treatment at baseline: ? Currently undergoing non-pharmacological treatment (e.g., cognitive behavioral therapy, neurofeedback, working memory training, etc.) ? Expected to change the type or dosage of medication during the clinical trial period 4. Individuals who are currently participating in another clinical trial or have participated in another clinical trial within 90 days prior to the screening date 5. Individuals who are deemed inappropriate for clinical trial participation due to ethical concerns or potential impact on the trial results, as determined by the investigator *Specific reasons must be documented in the case report form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-ARS (Korean version of the ADHD Rating Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| CPRS (Conners' Parent Rating Scale);K-CBCL (Korean version of the Child Behavior Checklist);stroop test (Stroop Color and Word Test);CAT (Children's Apperception Test);K-WISC-V (Korean-Wechsler Intelligence Scale for Children – Fifth Edition) | — |
Countries
Korea, Republic of
Contacts
Public ContactNAYEONG KONG
Keimyung University Dongsan Hospital
Outcome results
None listed