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MRI Markers of Outcome After Severe Pediatric TBI

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT02688660
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
82
Enrollment
21
Locations
73
Actual Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI Scans

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 Design

Study Type:
Observational
Actual Enrollment :
82 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
MRI Markers of Outcome After Severe Pediatric Traumatic Brain Injury (TBI)
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cerebral Atrophy [1 year]

    Global and regional cerebral atrophy will be assessed using MRI

  2. White matter fractional anisotropy [1 year]

    Fractional Anisotropy will be assessed using Diffusion Tensor MRI

  3. Brain network connectivity [1 year]

    Network connectivity will be assessed using resting-state functional MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phoenix Children's Hospital Phoenix Arizona United States 85016
2 UC San Diego Health Sciences Center San Diego California United States 92103
3 Children's National Medical Center Washington District of Columbia United States 20009
4 Children's Healthcare of Atlanta Atlanta Georgia United States 30342
5 Johns Hopkins University Baltimore Maryland United States 21218
6 Boston Children's Hospital Boston Massachusetts United States 02115
7 Washington University School of Medicine Saint Louis Missouri United States 63110
8 Cincinnati Children's Hospital Cincinnati Ohio United States 45229
9 Nationwide Children's Hospital Columbus Ohio United States 43205
10 Penn State Hershey Children's Hospital Hershey Pennsylvania United States 17033
11 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
12 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
13 University of Tennessee Knoxville Tennessee United States 37996
14 University of Texas Southwestern Medical Center Dallas Texas United States 75390
15 University of Utah Primary Children's Medical Center Salt Lake City Utah United States 84108
16 Virginia Commonwealth University Richmond Virginia United States 23284
17 Seattle Children's Hospital Seattle Washington United States 98105
18 American Family Children's Hospital (AFCH) Madison Wisconsin United States 53792
19 The Royal Children's Hospital Melbourne Victoria Australia 3052
20 Birmingham Children's Hospital Birmingham England United Kingdom B4 6NH
21 University Hospital Southampton Southampton Hampshire United Kingdom SO16 6YD

Sponsors and Collaborators

  • University of Wisconsin, Madison
  • National Institutes of Health (NIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02688660
Other Study ID Numbers:
  • 2015-0185
  • R01NS092870
  • A536700
  • PEDIATRICS-GEN
  • Protocol Version 8/28/2019
First Posted:
Feb 23, 2016
Last Update Posted:
Jun 24, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University of Wisconsin, Madison
Pediatrics
Neuroimaging
Additional relevant MeSH terms:
Brain Injuries

Study Results

No Results Posted as of Jun 24, 2022