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:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01132898
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 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.

Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Changes in other clinical phenotyping measures over time

Estimated Enrollment: 300
Study Start Date: May 2010
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.

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.

  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 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.

  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: NCT01132898

Contacts
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

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01132898     History of Changes
Other Study ID Numbers: 100118, 10-CC-0118
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):
Traumatic Brain Injury
Biomarkers
Magnetic Resonance Imaging (MRI)
DTI
Functional Capacity
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 September 16, 2014