Long-term Clinical Correlates of Traumatic Brain Injury
|First Received Date ICMJE||May 27, 2010|
|Last Updated Date||June 30, 2017|
|Start Date ICMJE||May 6, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To observe changes in the TBI Common Data Elements over time [ Time Frame: Ongoing ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01132898 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Long-term Clinical Correlates of Traumatic Brain Injury|
|Official Title ICMJE||Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters|
- 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.
- 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.
- Individuals between 18 and 70 years of age who have had a traumatic brain injury within the past 6 months.
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.
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. Additionally, fifty adult healthy volunteers without a history of TBI will be seen for comparison.
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. In addition to the TBI patient group, a longitudinal control group comprised of healthy volunteers will be collected. The control group participants may complete the Neuroimaging (MRI without gadolinium), hematological and functional/cognitive phenotyping measures as the TBI patient population.
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), high field 7T MRI and PET-MR. In addition, extensive and sensitive clinical phenotyping will be performed to assess functional and cognitive impairment, and quality of life assessments. Blood and saliva (buccal cells may be collected in lieu of whole blood for subjects unwilling or unable to provide blood draw) may also be collected and sent to a biorepository for future analysis if subject agrees to participation in sample collection.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Traumatic Brain Injury|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||350|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects eligible for participation in the prospective cohort must meet the following inclusion criteria:
Subjects eligible for participation in the cross-sectional sub-study must meet the following inclusion criteria:
Subjects eligible for participation in the healthy volunteer control group must meet the following inclusion criteria:
Subjects are not eligible for participation in the prospective cohort if any of the following conditions exist:
Subjects are not eligible for participation in the cross-sectional sub-study if any of the following conditions exist:
Subjects are not eligible for participation in the healthy volunteer control group if any of the following conditions exist:
Alcohol abuse we define as 'Women consuming more than seven drinks of alcohol per week, and men consuming more than 14 drinks of alcohol per week in the last six months. Men or women consuming more than five drinks of alcohol at one time in the last six months. This definition is provided by The National Institute on Alcohol Abuse & Alcoholism (NIAAA) as moderate alcohol usage.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01132898|
|Other Study ID Numbers ICMJE||100118
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 15, 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP