The Role of Cerebral Oximetry in Pediatric Concussion Assessment

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Johns Hopkins University
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Elizabeth Hines, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02036333
First received: January 13, 2014
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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
Concussion, Brain
Concussion, Mild
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Concussion Group
Control Group

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036333

Contacts
Contact: Elizabeth Q Hines, MD 4048406490 lizquaal@gmail.com
Contact: Jennifer F Anders, MD 4109556143 janders74@gmail.com

Locations
United States, Maryland
Johns Hopkins University Pediatric Emergency Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Elizabeth Q Hines, MD    404-840-6490    lizquaal@gmail.com   
Principal Investigator: Elizabeth Q Hines, MD         
Sub-Investigator: Jennifer F Anders, MD         
Sponsors and Collaborators
Johns Hopkins University
Covidien
Investigators
Principal Investigator: Elizabeth Q Hines, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Elizabeth Hines, Clinical Fellow, Pediatric Emergency Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02036333     History of Changes
Other Study ID Numbers: NA_00078909
Study First Received: January 13, 2014
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
near infrared spectroscopy
pediatrics

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on July 28, 2014