The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2015

Arms, Groups and Cohorts

  • Concussion Group
  • Control Group

Clinical Trial Outcome Measures

Primary Measures

  • 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 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • Medtronic – MITG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jennifer Anders, MD, Principal Investigator, Johns Hopkins University

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