The Role of Cerebral Oximetry in Pediatric Concussion Assessment
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02036333
Recruitment Status :
(Key Personnel Left Institution Prior to Study Completion)
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls. [ Time Frame: At presentation (Day 0) ]
Secondary Outcome Measures :
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls. [ Time Frame: At presentation (Day 0) ]
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls. [ Time Frame: At presentation (Day 0) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This pilot study will employ a prospective cohort study design. Children aged 10-18 years will be recruited within the Johns Hopkins Hospital Pediatric Emergency Department (JHH PED) to participate in this study. All children must be conversant in English.
Age 10-18 years at time of visit
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).
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.