The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02036333

Enrollment

Registered

2014-01-15

Start date

2014-01-31

Completion date

2015-06-30

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Brain, Concussion, Mild, Traumatic Brain Injury

Keywords

near infrared spectroscopy, pediatrics

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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.	At presentation (Day 0)

Secondary

Measure	Time frame
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.	At presentation (Day 0)
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.	At presentation (Day 0)

Countries

United States

Outcome results