Long-term Clinical Correlates of Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

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

Status Suspended

Clinical Trial 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.

Clinical Trial 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

This is a natural history study following a prospective cohort of subjects with a clinical diagnosis of non-penetrating 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), 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 may be evaluated with MRI, hematological, and functional/cognitive measures usually within a single visit. However, procedures may be scheduled during multiple visits, depending on the number of procedures performed. Study participants may be offered standard of care rehabilitation therapies provided at no cost by Investigators and supervised by Dr. Chan. Tests will be subject to investigator discretion and subject willingness to participate in evaluation. After first MRI, future MRIs will be obtained based on subject willingness and investigator discretion from findings on previous imaging. 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 may have diagnostic value and rehabilitation therapies that might 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.

The prospective select exposure group of US government associated personnel will be followed periodically for a total of six years. Subjects may complete neuroimaging, including Magnetic Resonance Imaging (MRI), hematological, and extensive functional/cognitive, auditory, vestibular, and oculomotor phenotyping measures. In addition to the select exposure group, a longitudinal control group comprised of unaffected volunteers matched to this group will be collected. The control group participants will complete the same Neuroimaging (MRI without gadolinium), hematological and functional/cognitive phenotyping measures as the select exposure patient population. Additionally, if a select exposure matched control participant is subsequently exposed, they may enroll into the select exposure group arm of the study for pre and post exposure analysis. Participants who are unable to travel to the NIH Clinical Center to participate can remote consent, answer questionnaires remotely via telephone or electronic communication methods, and have biospecimens sent to our lab for analysis. Participants enrolled in the any arm of the study who are unable to travel to NIH for any study visit may be asked to answer questions electronically (telephone, email, videoconferencing if within the US, etc) to allow for some data collection to occur at each time point.

Outcome Measures

A variety of outcome measures may be used including MRI, to include Diffusion Tensor Imaging (DTI), Dynamic Susceptibility Contrast (DSC), and functional Magnetic Resonance Imaging (fMRI), high field 7T MRI. In addition, extensive and sensitive clinical phenotyping will be performed to assess functional and cognitive impairment, including auditory, vestibular, and oculomotor testing, 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. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

• NCT number: NCT01132898
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Suspended
• Start date: March 31, 2011