The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Stopped early

Conditions studied: Concussion, Brain, Concussion, Mild, Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT02036333

Run by

Johns Hopkins University

People needed

59

Starts

2014-01-01

Expected to finish

2015-06-30

Last updated by the study team

2018-02-05

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University Pediatric Emergency Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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