Clinical trial NCT02036333: The Role of Cerebral Oximetry in Pediatric Concussion Assessment
Official title: The Role of Cerebral Oximetry in Pediatric Concussion Assessment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Concussion, Brain
Concussion, Mild
Traumatic Brain Injury
Keywords: near infrared spectroscopy
pediatrics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-01-15
Enrollment: 59
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls.
timeFrame: At presentation (Day 0)
Secondary outcomes:
measure: Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.
timeFrame: At presentation (Day 0)
measure: Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.
timeFrame: At presentation (Day 0)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Pediatric Emergency Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jennifer Anders, MD
role: PRINCIPAL_INVESTIGATOR
References: