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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT05105802
Eligibility Criteria:
Inclusion Criteria:
* Subjects presenting to CHEO's Emergency Department (ED) within 48 hours of sustaining a direct or indirect head injury
* Aged 12 through 17.99 years
* Have a concussion, as defined by the Berlin consensus statement
* Score \>4 on the predicting persistent postconcussive problems in pediatric (5P) clinical rule
* Proficient in English.
Exclusion Criteria:
* Glasgow Coma Scale ≤13
* Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required but may be performed if clinically indicated)
* Neurosurgical operative intervention, intubation, or intensive care required
* Multi-system injuries with treatment requiring hospital admission, operating room, or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)
* Severe chronic neurological developmental delay resulting in communication difficulties
* Intoxication at the time of ED presentation as per clinician judgment
* History of trauma as primary events (e.g., seizure, syncope, migraine)
* Prior psychiatric hospitalization
* Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression is not exclusionary)
* Inability to obtain a proper written informed consent/assent (e.g., language barrier, absence of parental authority, developmental delay, intoxication, patients too confused to consent)
* Legal guardian not present (certain forms need to be completed by parents/legal guardians)
* No Internet or mobile/tablet access.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05105802
Study Brief:
Protocol Section:
NCT05105802