The Role of Cerebral Oximetry in Pediatric Concussion Assessment

January 31, 2018 updated by: Johns Hopkins University
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 Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University Pediatric Emergency Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
Concussion Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At presentation (Day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
At presentation (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Jennifer Anders, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00078909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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