Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07323004
Eligibility Criteria:
Inclusion Criteria:
* Children aged 4 to 12 years
* Born at full term (gestational age ≥ 37 weeks and \< 42 weeks)
* Provided informed consent signed by their legal guardian
* For the ADHD group:
* Diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by a qualified physician (e.g., child psychiatrist or psychologist) according to DSM-5 diagnostic criteria
* For the typical development (control) group:
* No symptoms related to ADHD (e.g., inattention, hyperactivity, impulsivity)
* Normal scores on parent- and teacher-rated behavioral questionnaires (e.g., CBCL, SDQ)
* No history of neurological or psychiatric disorders
Exclusion Criteria:
* Diagnosis of other neurodevelopmental disorders, such as:
* Autism Spectrum Disorder (ASD)
* Learning disabilities
* Epilepsy, cerebral palsy, or other neurological conditions
* Developmental quotient (DQ) \< 85, as measured by standardized tools (e.g., Gesell scale)
* Significant visual or hearing impairments, or congenital malformations
* History of high-risk birth events, including but not limited to:
* Severe birth asphyxia
* Intrauterine infections
* Presence of genetic or metabolic disorders, or severe dysfunction of vital organs
* For the ADHD group: comorbid psychiatric conditions (e.g., schizophrenia, severe mood disorders)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT07323004
Study Brief:
Protocol Section:
NCT07323004