The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Johns Hopkins University

Status: Terminated

Conditions: Traumatic Brain Injury; Concussion, Mild; Concussion, Brain

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02036333

NA_00078909

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

59 participants in 2 patient groups

Concussion Group

Control Group