MRI Markers of Outcome After Severe Pediatric TBI

NCT ID: NCT02688660

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2022-05-31

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.

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.

Conditions

Brain Injuries

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

MRI Scans

Intervention Type: OTHER

Healthy Controls

This cohort will have one MRI to be used in comparison of the above cohorts.

MRI Scans

Intervention Type: OTHER

Interventions

MRI Scans

Intervention Type: OTHER

Eligibility 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.).

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Ferrazzano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

UC San Diego Health Sciences Center

San Diego, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Tennessee

Knoxville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Utah Primary Children's Medical Center

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

American Family Children's Hospital (AFCH)

Madison, Wisconsin, United States

The Royal Children's Hospital

Melbourne, Victoria, Australia

Birmingham Children's Hospital

Birmingham, England, United Kingdom

University Hospital Southampton

Southampton, Hampshire, United Kingdom

Countries

United States; Australia; United Kingdom

References

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Reference Type: BACKGROUND

PMID: 23876117 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23815563 (View on PubMed)

Beers SR, Wisniewski SR, Garcia-Filion P, Tian Y, Hahner T, Berger RP, Bell MJ, Adelson PD. Validity of a pediatric version of the Glasgow Outcome Scale-Extended. J Neurotrauma. 2012 Apr 10;29(6):1126-39. doi: 10.1089/neu.2011.2272. Epub 2012 Apr 10.

Reference Type: BACKGROUND

PMID: 22220819 (View on PubMed)

McCauley SR, Wilde EA, Anderson VA, Bedell G, Beers SR, Campbell TF, Chapman SB, Ewing-Cobbs L, Gerring JP, Gioia GA, Levin HS, Michaud LJ, Prasad MR, Swaine BR, Turkstra LS, Wade SL, Yeates KO; Pediatric TBI Outcomes Workgroup. Recommendations for the use of common outcome measures in pediatric traumatic brain injury research. J Neurotrauma. 2012 Mar 1;29(4):678-705. doi: 10.1089/neu.2011.1838. Epub 2011 Aug 24.

Reference Type: BACKGROUND

PMID: 21644810 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17599699 (View on PubMed)

Other Identifiers

R01NS092870

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A536700

Identifier Type: OTHER

Identifier Source: secondary_id

PEDIATRICS-GEN

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/28/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0185

Identifier Type: -

Identifier Source: org_study_id