The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Study Overview
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Brief Summary
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The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.

Official Title
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The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Conditions
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Concussion, Brain, Concussion, Mild, Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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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: 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) Physical Signs (ie. loss of consciousness, unsteadiness) 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concussion Group<br> | |
| Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls. |  | At presentation (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls. |  | At presentation (Day 0) | 
| Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls. |  | At presentation (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near infrared spectroscopy, pediatrics