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Long-term Clinical Correlates of Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT01132898
Recruitment Status : Recruiting
First Posted : May 28, 2010
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Center for Neuroscience and Regenerative Medicine (CNRM)
United States Department of Defense
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief 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 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 or disease
Traumatic Brain Injury

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters
Study Start Date : May 7, 2010

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. To observe changes in the TBI Common Data Elements over time [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. Changes in other clinical phenotyping measures over time [ Time Frame: Ongoing ]
  2. Changes in MRI findings over time [ Time Frame: Ongoing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Center for Neuroscience and Regenerative Medicine (CNRM)
United States Department of Defense
Investigators
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01132898     History of Changes
Other Study ID Numbers: 100118
10-CC-0118
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 14, 2019

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:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System