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The Role of Cerebral Oximetry in Pediatric Concussion Assessment

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ClinicalTrials.gov Identifier: NCT02036333
Recruitment Status : Terminated (Key Personnel Left Institution Prior to Study Completion)
First Posted : January 15, 2014
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease
Concussion, Brain Concussion, Mild Traumatic Brain Injury

Study Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Cerebral Oximetry in Pediatric Concussion Assessment
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015
Groups and Cohorts
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Group/Cohort
Concussion Group
Control Group


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036333


Locations
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United States, Maryland
Johns Hopkins University Pediatric Emergency Medicine
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Medtronic - MITG
Investigators
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Principal Investigator: Jennifer Anders, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02036333    
Other Study ID Numbers: NA_00078909
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Keywords provided by Johns Hopkins University:
near infrared spectroscopy
pediatrics
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating