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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT02893969
Eligibility Criteria:
Inclusion Criteria:
Subjects presenting to one of the study hospital EDs after sustaining a direct or indirect head injury will be eligible if they:
* aged 10 through 17.99 years;
* have a concussion, defined by Zurich consensus statement;
* suffered the initial injury in the previous 48 hours;
* are proficient in English or French.
Exclusion Criteria:
Patients will be excluded if they present with traumatic head injuries with any of the following:
* 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;
* no clear history of trauma as primary events (e.g., seizure, syncope or migraine);
* inability to resume physical activities (e.g., fractured extremity or other concomitant injuries);
* inability to obtain a proper written informed consent/assent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.);
* legal guardian not present (certain forms need be completed by parents/legal guardians).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT02893969
Study Brief:
Protocol Section:
NCT02893969