Bethesda, Maryland 20892


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.


Study summary:

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. Additionally, a select group of up to 40 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 80 unaffected volunteers. 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. 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) and Positron Emission Tomography (PET), 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. 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), 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.


Criteria:

- INCLUSION CRITERIA: Subjects eligible for participation in the TBI 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 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 Subjects eligible for participation in the healthy volunteer control group must meet the following inclusion criteria: - Age 18 and older - Able to provide written informed consent - Able to lie flat for up to 2 hours - Good general medical and psychological health based on History and Physical (H&P) Subjects eligible for participation in the Select Exposure Matched Unaffected volunteer control group must meet the following inclusion criteria: - Age 18 and older - Able to provide written informed consent - Able to lie flat for up to 2 hours - Good general medical and psychological health based on History and Physical (H&P) Subjects eligible for participation in the Select Exposure Matched Unaffected volunteer control group must meet the following inclusion criteria: - Able to provide written informed consent - Able to lie flat for up to 2 hours - Good general medical and psychological health based on History and Physical (H&P) 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-MRI. - 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. Subjects are not eligible to participate in the Select Exposure 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-MRI or gadolinium. - 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 (such schizophrenia, uncontrolled hypertension, serious heart, lung, or kidney disease, or other condiditon that would make participation unsafe) Subjects are not eligible for participation in the healthy volunteer control group 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). - Pregnant women - Inability to read or speak enough English to complete the clinical phenotyping testing. - History of a head injury, regardless of cause:.(Causes including: vehicle/bicycle accidents, falls, sports injuries, firearm injuries, blast injuries, violent shaking, etc) - Weight more than 250 lbs. - Height greater than 6 4 - Any current or prior alcohol or substance abuse. Heavy alcohol use: The Substance Abuse and Mental Health Services Administration (SAMHSA) defines heavy alcohol use as binge drinking on 5 or more days in the past month. SAMHSA defines binge drinking as 5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month. Subjects are not eligible for participation in the Select Exposure Matched Unaffected volunteer group 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). - Pregnant women - Inability to read or speak enough English to complete the clinical phenotyping testing. - Weight more than 250 lbs. - Height greater than 6 4 - Any current or prior heavy alcohol or substance use. - Have a medical or psychological condition, such schizophrenia, uncontrolled hypertension, serious heart, lung, or kidney disease, or other condition that would make it difficult for to do the study tests, might make participation unsafe, or would interfere with the study result


NCT ID:

NCT01132898


Primary Contact:

Principal Investigator
Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)

Andre J Van Der Merwe
Phone: (301) 496-4733
Email: andre.vandermerwe@nih.gov


Backup Contact:

Email: chanle@mail.nih.gov
Leighton Chan, M.D.
Phone: (301) 496-4733


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone: 800-411-1222
Email: prpl@cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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