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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05577533
Eligibility Criteria:
Inclusion Criteria:
* Boys or girls
* Aged 7 to 12 years
* Fluent in the French language
* Agreement and signature of informed consent by the child
* Agreement and signature of informed consent by one of the legal representatives
* Estimated intelligence quotient \> 85
Exclusion Criteria:
* No biological parent or legal guardian is able to give permission for the minor and agrees to participate in parental assessments
* Prematurity or other perinatal complications that required significant intervention
* History of neurological disorders, including seizure disorders, cerebral palsy, or other conditions requiring neurological or medical care :
* History of head injury:
* Head trauma more than one year old with loss of consciousness \>30 minutes, OR
* Had to be hospitalized for head trauma, OR
* Amnesia \> 24 hours, OR
* Confusion or loss of orientation \>24 hours, OR
* A brain scan revealed problems following a head injury, OR
* Head trauma within the past year with loss of consciousness \>10 minutes. Current or persistent major Axis I psychiatric disorder that may interfere with successful completion of the protocol (e.g., psychosis and bipolar disorder), or substance use disorder.
Current use of medications with significant effects on brain function or blood flow (e.g., antipsychotics, mood stabilizers); Attention Deficit Hyperactivity Disorder (ADHD) medications and Selective Serotonin Reuptake Inhibitors (SSRIs) are not excluded as the use of these medications is associated with certain neurodevelopmental disorders and assessment of these individuals will provide useful data to the community Not fluent in French (all youth materials are in French) Uncorrectable visual, hearing, or sensorimotor impairment, as the protocol items may not be valid.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT05577533
Study Brief:
Protocol Section:
NCT05577533