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TerminatedNCT02036333Updated Feb 5, 2018

The Role of Cerebral Oximetry in Pediatric Concussion Assessment

An observational study in Concussion, Brain, Concussion, Mild and Traumatic Brain Injury, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Johns Hopkins University · Observational

Why this study was terminated
Key Personnel Left Institution Prior to Study Completion
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
59
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Concussion, Brain
  • Concussion, Mild
  • Traumatic Brain Injury

Keywords

  • near infrared spectroscopy
  • pediatrics
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 59 is below the median of 100 across 689 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
59 participants (actual)
Patient registry
No

Groups and cohorts

  • Concussion Group
  • Control Group
06

What researchers measure

Primary outcomes

  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 outcomes

  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)

07

Study locations

1 site
  • Johns Hopkins University Pediatric Emergency Medicine
    Baltimore, Maryland 21224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02036333
Lead sponsor
Johns Hopkins University
Collaborators
Medtronic - MITG
Responsible party
Sponsor
First posted
Jan 15, 2014
Start date
Jan 2014
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015
Last update
Feb 5, 2018

Study contacts

Jennifer Anders, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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