The Role of Cerebral Oximetry in Pediatric Concussion Assessment

NCT ID: NCT02036333

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Concussion, Brain; Concussion, Mild; Traumatic Brain Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Concussion Group

No interventions assigned to this group

Control Group

No interventions assigned to this group

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Anders, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University Pediatric Emergency Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00078909

Identifier Type: -

Identifier Source: org_study_id