The Role of Cerebral Oximetry in Pediatric Concussion Assessment

NCT02036333 | Terminated

• 1 other identifier: NA_00078909
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

near infrared spectroscopy; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Concussion Group

Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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:
• 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)
• Physical Signs (ie. loss of consciousness, unsteadiness)
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Johns Hopkins University Pediatric Emergency Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jennifer Anders, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: January 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

US (1)