MRI Markers of Outcome After Severe Pediatric TBI

June 22, 2022 updated by: University of Wisconsin, Madison

MRI Markers of Outcome After Severe Pediatric Traumatic Brain Injury (TBI)

Traumatic brain injury (TBI) is the leading cause of death or disability in children. Each year in the United States, pediatric TBI results in an estimated 630,000 emergency room visits, 58,900 hospitalizations, and 7000 deaths. The incidence of long-term disability after severe TBI is high, with over 60% of children requiring educational or community based supportive services 12 months post-injury. Over 5,000 children require inpatient rehabilitation after TBI each year and an estimated 145,000 US children are currently living with disabilities after a severe TBI. Hospital costs for the acute treatment of children with TBI are estimated at ~$2.6 billion each year, while the gross annual costs accounting for long-term care and lost productivity approach $60 billion. Therefore, pediatric TBI is a major public health concern and new ways to diagnose and treat TBI are urgently needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe pediatric TBI results in a range of neurocognitive and behavioral deficits with resultant impact on school performance, social functioning, and quality of life. Sixty percent of children suffer from long-term functional impairments after severe TBI, and more than 40% demonstrate deficits in multiple cognitive and psychological domains. Importantly, a recent meta-analysis revealed that rather than catching up to their peers in these domains, children with severe TBI fall further behind over time. These deficits in cognitive and emotional function have a major impact on the child's quality of life after a TBI. A large study recently reported that severe TBI patients demonstrated lower quality of life than children undergoing active treatment for cancer. Considerable variation exists in the severity of impairment within each cognitive domain from patient to patient, likely relating to the mechanism of injury, the type and location of lesion, patient age, and pre-morbid functioning among other factors. While clinical scales such as the Glasgow Coma Scale (GCS) are useful for assessing injury severity and may provide general prognostic information, they are insufficient to identify risk for specific cognitive deficits. Identifying predictors of impairment within specific domains would aid in directing rehabilitation strategies towards at-risk cognitive domains, thereby improving long-term function and quality of life.

The investigators are partnering with an ongoing pediatric TBI trial (ADAPT Trial: Approaches and Decisions in Acute Pediatric TBI) and will also be enrolling past UW patients and healthy controls. Consistency in timing of follow-up scans, large sample size and access to the ADAPT Trial injury severity data and neuropsychological testing will give this study unprecedented power to assess the relationship between early MRI findings and subsequent atrophy, white matter injury, network connectivity changes and neurocognitive and behavioral impairments.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • The Royal Children's Hospital
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Birmingham Children's Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • San Diego, California, United States, 92103
        • UC San Diego Health Sciences Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Children's National Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Children's Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Primary Children's Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • American Family Children's Hospital (AFCH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients who have experienced TBI and had an acute MRI scan and those who participate in the prospective phase and obtain a follow-up MRI. Healthy controls will also be enrolled.

Description

Inclusion Criteria:

Aim 1 Subjects:

  • Children 0 through < 18 years of age
  • Diagnosis of severe TBI (defined as a Glasgow Coma Scale (GCS) score less than or equal to 8)
  • Had an intracranial pressure (ICP) monitor as part of standard care

Aims 2 & 3 Subjects:

  • Children 9 through < 18 years of age with severe TBI
  • Consent for a follow-up MRI within 10 years of the time of TBI

Controls:

  • Healthy children greater than or equal to 9 and < 18 years of age.

Exclusion Criteria:

  • TBI & controls:
  • Anyone unable to tolerate a non-sedated MRI

Controls:

  • Any history of head injury resulting in loss of consciousness
  • Standard contraindications to MRI (metallic implants, implanted electronic devices, pregnancy, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ADAPT Study Population
This cohort will be subjects from the ADAPT study who had an acute MRI scan which has been uploaded into the ADAPT database from all participating sites.
Follow-Up MRI
This cohort will include patients from ADAPT sites who choose to participate in this option and obtain a follow-up MRI approximately 1 year after the TBI.
Other: MRI Scans
Healthy Controls
This cohort will have one MRI to be used in comparison of the above cohorts.
Other: MRI Scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Atrophy
Time Frame: 1 year
Global and regional cerebral atrophy will be assessed using MRI
1 year
White matter fractional anisotropy
Time Frame: 1 year
Fractional Anisotropy will be assessed using Diffusion Tensor MRI
1 year
Brain network connectivity
Time Frame: 1 year
Network connectivity will be assessed using resting-state functional MRI
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Peter Ferrazzano, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

May 1, 2022

Study Completion (ACTUAL)

May 1, 2022

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (ESTIMATE)

February 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0185
  • A536700 (Other Identifier: UW Madison)
  • R01NS092870 (NIH)
  • PEDIATRICS-GEN (OTHER: UW Madison)
  • Protocol Version 8/28/2019 (OTHER: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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