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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02036333
Eligibility Criteria:
INCLUSION CRITERIA:
All Participants
* Age 10-18 years at time of visit
Concussion Group
* Present to JHH PED within the first 24 hours following trauma.
* Diagnosis of concussion as defined by the 3rd International Conference on Concussion in Sport (McCrory), including the presence of any one or more of the following:
1. Symptoms (ie. headache, neck pain, nausea/vomiting, dizziness, blurred vision, balance problems, sensitive to light, sensitivity to noise, feeling slowed down, feeling in a fog, difficulty concentrating, difficulty remembering, fatigue, confusion, drowsiness, more emotional, irritability, sadness, nervous)
2. Physical Signs (ie. loss of consciousness, unsteadiness)
3. Impaired brain function (ie. confusion)
* Glasgow Coma Score of 13-15 upon arrival to JHH PED.
* Loss of consciousness of less than 15 minutes (if applicable).
* No structural intracranial injuries identified on neuroimaging (if completed).
EXCLUSION CRITERIA
All Participants
* History of prior concussion or traumatic brain injury within preceding 6 weeks.
* History of prior intracranial disease or mass (ie. tumor, intraventricular hemorrhage, etc.)
* Presence of intracranial hardware.
* Complaints of respiratory distress, tachypnea or hypoxia, which may affect regional cerebral oxygen saturation.
* Inability to stand secondary to lower extremity disease or trauma, which is required for completion of SCAT2.
* Inability to complete SCAT2 questionnaire secondary to developmental delay.
* Child in foster care or legal guardian not available.
* Participant known to be pregnant, which alters total body blood flow and likely affects regional cerebral oxygen saturation.
* Non-English speaking.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT02036333
Study Brief:
Protocol Section:
NCT02036333