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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CC-0118

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking

Keywords

Traumatic Brain Injury;
Biomarkers;
Functional Level;
DTI;
Neuropsychological Assessment;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Traumatic Brain Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical CenterCenter for Neuroscience and Regenerative Medicine (CNRM)Department of Defense

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.

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Eligibility

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 prospective cohort must meet the following inclusion criteria:

--Referral from US State Department, Department of Health and Human Services or other governmental entity based on their assessment of symptomatology and potential exposure (may include, for example, abnormal auditory sensations and subsequent oculomotor, vestibular, and cognitive symptoms)

--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 Select Exposure Matched Unaffected volunteer control group must meet the following inclusion criteria:

--Age 18 and older

--Able to provide written informed consent

--Good general medical and psychological health based on History and Physical (H&P)

Subjects eligible for participation in the Remote Select Exposure Samples cohort must meet the following inclusion criteria:

--Referral from US State Department, Department of Health and Human Services or other governmental entity based on their assessment of symptomatology and potential exposure (may include, for example, abnormal auditory sensations and subsequent oculomotor, vestibular, and cognitive symptoms)

--Age 18 years of age and older

--Able to provide informed consent (telephone or electronic signature)

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:

--Pregnant women, may enroll in the study, but will not receive an MRI.

--Women who are breast-feeding may enroll in the study, but will not receive contrast MRI (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:

--Pregnant women, may enroll into the study but will not receive an MRI

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

--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

Subjects are not eligible for participation in the Remote Select Exposure Samples group if any of the following conditions exist:

--Have a blood disorder (such as anemia, bleeding disorders such as hemophilia, blood clots, and blood cancers such as leukemia, lymphoma, and myeloma) which would make participation in a blood draw dangerous, or would interfere with the study results

--Have a medical or psychological condition, such schizophrenia, uncontrolled hypertension serious heart, lung, or kidney disease, or other condition that would make it difficult to complete the study tests, might make participation unsafe, or would interfere with the study result


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 1-1469
10 CENTER DR
BETHESDA MD 20892
(301) 496-4733
chanle@mail.nih.gov

Andre J. Van Der Merwe
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1360
10 Center Drive
Bethesda, Maryland 20892
(301) 496-4733
andre.vandermerwe@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01132898

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