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MRI Markers of Outcome After Severe Pediatric TBI

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ClinicalTrials.gov Identifier: NCT02688660
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2016
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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
Brain Injuries 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.


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Study Type : Observational
Estimated Enrollment : 950 participants
Observational Model: Other
Time Perspective: Other
Official Title: MRI Markers of Outcome After Severe Pediatric Traumatic Brain Injury (TBI)
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

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



Primary Outcome Measures :
  1. Cerebral Atrophy [ Time Frame: 1 year ]
    Global and regional cerebral atrophy will be assessed using MRI

  2. White matter fractional anisotropy [ Time Frame: 1 year ]
    Fractional Anisotropy will be assessed using Diffusion Tensor MRI

  3. Brain network connectivity [ Time Frame: 1 year ]
    Network connectivity will be assessed using resting-state functional MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688660


  Show 26 Study Locations
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)

Publications:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02688660     History of Changes
Other Study ID Numbers: 2015-0185
R01NS092870 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University of Wisconsin, Madison:
Pediatrics
Neuroimaging
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System