MRI Markers of Outcome After Severe Pediatric TBI

NCT02688660 | Completed

• 5 other identifiers: 2015-0185R01NS092870A536700PEDIATRICS-GENProtocol Version 8/28/2019
• Study Type: observational
• Target: 82
• Locations: 3 countries
• Sites: 21

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.

Conditions

Brain Injuries

Keywords

Pediatrics; Neuroimaging

Outcome Measures

Primary Outcomes (3)

• Cerebral Atrophy

  Global and regional cerebral atrophy will be assessed using MRI

  1 year

• White matter fractional anisotropy

  Fractional Anisotropy will be assessed using Diffusion Tensor MRI

  1 year

• Brain network connectivity

  Network connectivity will be assessed using resting-state functional MRI

  1 year

Study Arms (3)

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

Interventions

MRI Scans OTHER

Follow-Up MRI; Healthy Controls

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (21)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

UC San Diego Health Sciences Center

San Diego, California, 92103, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20009, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah Primary Children's Medical Center

Salt Lake City, Utah, 84108, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

American Family Children's Hospital (AFCH)

Madison, Wisconsin, 53792, United States

Location

The Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (7)

• Bigler ED, Abildskov TJ, Petrie J, Farrer TJ, Dennis M, Simic N, Taylor HG, Rubin KH, Vannatta K, Gerhardt CA, Stancin T, Owen Yeates K. Heterogeneity of brain lesions in pediatric traumatic brain injury. Neuropsychology. 2013 Jul;27(4):438-51. doi: 10.1037/a0032837.

  PMID: 23876117 BACKGROUND

• Tasker RC, Westland AG, White DK, Williams GB. Corpus callosum and inferior forebrain white matter microstructure are related to functional outcome from raised intracranial pressure in child traumatic brain injury. Dev Neurosci. 2010;32(5-6):374-84. doi: 10.1159/000316806. Epub 2010 Sep 8.

  PMID: 20829579 BACKGROUND

• Birn RM, Shackman AJ, Oler JA, Williams LE, McFarlin DR, Rogers GM, Shelton SE, Alexander AL, Pine DS, Slattery MJ, Davidson RJ, Fox AS, Kalin NH. Evolutionarily conserved prefrontal-amygdalar dysfunction in early-life anxiety. Mol Psychiatry. 2014 Aug;19(8):915-22. doi: 10.1038/mp.2014.46. Epub 2014 May 27.

  PMID: 24863147 BACKGROUND

• Yue JK, Vassar MJ, Lingsma HF, Cooper SR, Okonkwo DO, Valadka AB, Gordon WA, Maas AI, Mukherjee P, Yuh EL, Puccio AM, Schnyer DM, Manley GT; TRACK-TBI Investigators. Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury. J Neurotrauma. 2013 Nov 15;30(22):1831-44. doi: 10.1089/neu.2013.2970. Epub 2013 Sep 24.

  PMID: 23815563 BACKGROUND

• 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.

  PMID: 22220819 BACKGROUND

• 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.

  PMID: 21644810 BACKGROUND

• Alexander AL, Lee JE, Lazar M, Field AS. Diffusion tensor imaging of the brain. Neurotherapeutics. 2007 Jul;4(3):316-29. doi: 10.1016/j.nurt.2007.05.011.

  PMID: 17599699 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Peter Ferrazzano, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 23, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (18); AU (1); GB (2)