Skip to main content
Clinical Trials/NCT01132898
NCT01132898SuspendedNot Applicable

Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters

National Institutes of Health Clinical Center (CC)1 site in 1 country354 target enrollmentStarted: March 31, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Enrollment
354
Locations
1
Primary Endpoint
The primary outcome measure will be to observe changes in the TBI Common Data Elements over time.

Study Overview

Brief Summary

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 natural history of traumatic brain injury by examining the changes in brain scans, blood samples, and brain function over 5 years after injury.

Eligibility:

  • Individuals 18 years of age and older who have had a traumatic brain injury within the past 1 year.

Design:

  • This study will include about eight visits to the NIH Clinical Center over 5 years. Participants will have four visits in the first year, and one visit each year for the following 4 years. Each visit will take between 1 and 4 days, and participants will be in the outpatient clinic for about 8 hours each day of the visit.
  • At each study visit, participants will have some or all of the following tests:
  • Medical history and physical examination
  • Blood and urine tests
  • Questionnaires and assessments of thinking and memory, which may be spoken aloud, written down, or entered into a computer
  • Imaging scans, such as magnetic resonance imaging (MRI) or positron emission tomography/computed tomography (PET/CT).
  • 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.

Detailed Description

Objective

The primary objective is to contribute to the understanding of non-penetrating traumatic brain injury (TBI) through the description of the relationships between neuroimaging, hematological, and extensive functional/cognitive phenotyping measures. We will generate natural history data for cohort-based comparisons and to serve as the basis for future hypothesis-driven protocols. In addition, we will create and test a series of new taxonomies to describe TBI severity and predict outcome.

Study Population

Three hundred adult subjects with a clinical diagnosis of non-penetrating TBI (mild, moderate and severe) will be enrolled. Subjects will be recruited from NIH, affiliated hospitals/clinics, and in the community. One hundred adult healthy volunteers without a history of TBI will be seen for comparison. Additionally, a select group of up to 115 US government associated personnel experiencing TBI-like symptoms arising after possible exposure to a non-natural energy source, will be studied (select exposure group). This select group will require a separate age and sex matched group of 115 unaffected volunteers. Participants (100) who are not able to travel to the NIH Clinical Center to participate in the Select Exposure Group study can complete study tests and questionnaires remotely, and have biospecimens sent to our lab for analysis, as part of the remote select exposure samples group.

Design

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The primary outcome measure will be to observe changes in the TBI Common Data Elements over time.

Time Frame: 30, 90, 180 days post injury, then annually out to 5 years.

See NINDS Common Data Elements for TBI

Secondary Outcomes

  • Changes in other clinical phenotyping measures over time(30, 90, 180 days post injury, then annually out to 5 years.)

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials