MRI Markers of Outcome After Severe Pediatric TBI

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University of Wisconsin (UW)

Status

Completed

Conditions

Brain Injuries

Treatments

Other: MRI Scans

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT02688660
R01NS092870 (U.S. NIH Grant/Contract)
2015-0185
A536700 (Other Identifier)
Protocol Version 8/28/2019 (Other Identifier)
PEDIATRICS-GEN (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

Under 18 years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial design

82 participants in 3 patient groups

ADAPT Study Population
Description:
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
Description:
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.
Treatment:
Other: MRI Scans
Healthy Controls
Description:
This cohort will have one MRI to be used in comparison of the above cohorts.
Treatment:
Other: MRI Scans

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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