The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Traumatic Brain Injury Clinical Trial

Official title:

The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02036333
• Other study ID #: NA_00078909
• Status: Terminated
• Phase: N/A
• First received: January 13, 2014
• Last updated: January 31, 2018
• Start date: January 2014
• Est. completion date: June 30, 2015

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Johns Hopkins University Pediatric Emergency Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.		At presentation (Day 0)