Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long-term Clinical Correlates of 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:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01132898
First received: May 27, 2010
Last updated: November 11, 2014
Last verified: December 2013

May 27, 2010
November 11, 2014
May 2010
Not Provided
  • To observe changes in the TBI Common Data Elements over time for the prospective cohort
  • The primary outcome measure for the cross-sectional sub-study will be evidence of injury on MRI of the brain, which will be described in relation to the TBI Common Data Elements.
Not Provided
Complete list of historical versions of study NCT01132898 on ClinicalTrials.gov Archive Site
Changes in other clinical phenotyping measures over time
Not Provided
Not Provided
Not Provided
 
Long-term Clinical Correlates of Traumatic Brain Injury
Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters

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 a the injury.

Eligibility:

- Individuals between 18 and 70 years of age who have had a traumatic brain injury within the past 6 months.

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.

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.

Design

This is a natural history study following a prospective cohort of subjects with a clinical diagnosis of non-penetrating acute traumatic brain injury with a cross-sectional sub-study. Subjects will be enrolled in the prospective cohort within one year of their head injury and then followed periodically for five years, with neuroimaging, including Magnetic Resonance Imaging (MRI) and Positron Emission Tomography Computed Tomography (PET-CT), hematological, and extensive functional/cognitive phenotyping measures. Subjects will be enrolled in the cross-sectional sub-study within five years of their head injury and will be evaluated with MRI, hematological, and functional/cognitive measures within a single visit. Subjects will be stratified according to findings into cohorts for comparison. Subjects will not be treated with experimental therapies as part of the research study. This study will provide direct benefit to subjects as they will receive sensitive neuro-imaging and clinical testing that will have diagnostic value and would ordinarily not be provided to them in the community.

Outcome Measures

A variety of outcome measures will be used including MRI, to include Diffusion Tensor Imaging (DTI), Dynamic Susceptibility Contrast (DSC), and functional Magnetic Resonance Imaging (fMRI), and PET-CT. In addition, extensive and sensitive clinical phenotyping will be performed to assess functional and cognitive impairment, and quality of life assessments. Serum will also be collected and sent to a biorepository for future analysis.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Traumatic Brain Injury
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
Not Provided
  • INCLUSION CRITERIA:

Subjects eligible for participation in the prospective cohort must meet the following inclusion criteria:

Diagnosis of non-penetrating mild, moderate, or severe TBI

Injury occurred less than one year before enrollment

Age 18 years of age and older

Able to provide informed consent or with a legally-authorized representative able to provide consent

Any subject enrolled in Dr. Latour's acute TBI protocol (10-N-N122) meeting inclusion/exclusion criteria of this protocol

Any subject who initially enrolls in the cross-sectional sub-study, but subsequently agrees to subsequent evaluations

Subjects eligible for participation in the cross-sectional sub-study must meet the following inclusion criteria:

Diagnosis of non-penetrating mild, moderate, or severe TBI

Injury occurred less than five years before enrollment

Age 18 years of age and older

Able to provide informed consent or with a legally-authorized representative able to provide consent

EXCLUSION CRITERIA:

Subjects are not eligible for participation in the prospective cohort if any of the following conditions exist:

Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a patient s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the patient s eyes).

Multiple trauma or accidents in the past with non-certainty that metal objects are still present in the body

Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).

Pregnant women.

Women who are breast-feeding may enroll in the study, but will not receive PET-CT.

Inability to read or speak enough English to complete the clinical phenotyping testing.

Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements.

Penetrating head injury.

Subjects are not eligible for participation in the cross-sectional sub-study if any of the following conditions exist:

Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a patient s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the patient s eyes).

Multiple trauma or accidents in the past with non-certainty that metal objects are still present in the body

Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).

Pregnant women.

Inability to read or speak enough English to complete the clinical phenotyping testing.

Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements.

Penetrating head injury.

Both
18 Years and older
No
Contact: Andre J Van Der Merwe (301) 496-4733 andre.vandermerwe@nih.gov
Contact: Leighton Chan, M.D. (301) 496-4733 chanle@mail.nih.gov
United States
 
NCT01132898
100118, 10-CC-0118
Not Provided
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
  • Center for Neuroscience and Regenerative Medicine (CNRM)
  • Department of Defense
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP