Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Henry Jackson Foundation
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01132937
First received: May 27, 2010
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

Background:

- Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury.

Objectives:

  • To study the MRI results of individuals who have recently had head injury and suspected traumatic brain injury.
  • To study the natural evolution of traumatic brain injury for up to 3 months after head injury.

Eligibility:

- Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed or suspected traumatic brain injury within the past 48 hours.

Design:

  • Participants will have two 3-hour study visits: an initial visit (within 48 hours of head injury) and a follow-up visit 4 days later. Participants may be asked to have an optional 90-day follow-up.
  • Each visit will involve blood samples, an MRI scan (approximately 30 minutes), and a series of tests to evaluate brain function.
  • At the optional follow-up visit, participants will have blood samples, an MRI scan, and a general traumatic brain injury assessment.
  • This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evidence of injury on MRI of the brain vasculature. Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, cognitive impairment, cognitive decline and TBI outcome s...

Secondary Outcome Measures:
  • Cognitive impairment or decline; success/failure rate for acute MRI in relationship to attempted and those able to undergo CT; imaging findings on CT in comparison to that of MRI; Neurocognitive testing and TBI Outcome Scales.

Estimated Enrollment: 1000
Study Start Date: May 2010
Detailed Description:

Objective

To generate natural history data for cohort-based comparisons to serve as the basis for future hypothesis-driven protocols and to contribute to the clinical and physiological understanding of traumatic brain injury (TBI) through the description of manifestations of the injury and the relationship among radiological, hematological, clinical variables and standard functional/cognitive outcome measures.

Study Population

Four hundred fifty male and female adult subjects with history of recent head injury with or suspected non-penetrating acute TBI, will be enrolled. Subjects having varying degrees of TBI severity will be recruited from the collaborative programs between NIH and non-NIH hospitals. We anticipate approximately 80% of subjects will be classified as mild TBI, concussion, or no injury, with approximately two thirds of those subjects enrolled being discharged directly from the emergency department.

Design

This is a prospective cohort study of subjects with known and suspected non-penetrating acute traumatic brain injury. Subjects presenting to the emergency department or trauma service at participating hospitals with a history of recent head injury will be studied during the course of their hospital stay and after discharge using radiological, hematological, clinical and functional/cognitive outcome measures. Subjects will be stratified according to findings into cohorts for comparison. The design is intentionally broad in scope to allow acquisition of initial data for the development of future hypothesis-driven protocols. Research performed under this protocol will not interfere with standard of care and subjects will not be treated with experimental therapies as part of the research study. Data collected under this research study may be shared without personal identifiers with other researchers if subjects approve this option on the informed consent.

Outcome Measures

A variety of outcome measures will be used including diagnosis, evidence of injury on magnetic resonance imaging (MRI), functional and cognitive impairment, and quality of life (QOL) assessments. The initial research questions will focus on a positive diagnosis of brain injury and monitoring the natural history. Statistical analysis plans will be developed as specific research questions and hypotheses are generated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Subjects eligible for participation in this research study must meet the following inclusion criteria:

  1. History of acute head injury with or suspected non-penetrating acute TBI
  2. Age 18 years or older
  3. Deemed medically safe for study participation by the subject s attending physician
  4. Able to provide consent or have a legally-authorized representative provide consent.

EXCLUSION CRITERIA:

Subjects are not eligible for participation in this research study if any of the following conditions exist:

  1. Considered to be psychiatrically unstable by the patient s attending physician
  2. Contraindication to MRI scanning including: pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments.
  3. Conditions precluding entry into the scanner such as morbid obesity or claustrophobia or conditions requiring sedation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132937

Contacts
Contact: Martin R Cota, CCRC (301) 435-9321 cotamr2@mail.nih.gov
Contact: Lawrence Latour, Ph.D. (301) 496-0463 latourl@ninds.nih.gov

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Maryland
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Henry Jackson Foundation
Investigators
Principal Investigator: Lawrence Latour, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01132937     History of Changes
Other Study ID Numbers: 999910122, 10-N-N122
Study First Received: May 27, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diffusion/Perfusion-MRI
Magnetic Resonance Imaging (MRI)
Traumatic Brain Injury
Brain Imaging
Brain Injuries
TBI

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014