Long-term Clinical Correlates of Traumatic Brain Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01132898|
Recruitment Status : Recruiting
First Posted : May 28, 2010
Last Update Posted : September 9, 2021
- 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.
- 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.
- Individuals between 18 and 70 years of age who have had a traumatic brain injury within the past 6 months.
- 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|
|Study Type :||Observational|
|Estimated Enrollment :||560 participants|
|Official Title:||Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters|
|Actual Study Start Date :||March 31, 2011|
Participants with a mild, moderate, or severe Traumatic Brain Injury enrolled within 5 years from injury. Seen at only one visit.
Healthy Volunteer with no history of TBI
Participants with a mild, moderate, or severe Traumatic Brain Injury enrolled within 1 year from injury.
Remote Select Exposure Samples
Participants who are unable to travel to the NIH Clinical Center to participate can remote consent, answer questionnaires remotely, and have biospecimens sent to our lab for analysis.
Select Exposure Group
US government associated personnel experiencing TBI-like symptoms arising after possible exposure to a non-natural energy source
Select Exposure Matched Unaffected
a longitudinal control group comprised of unaffected volunteers matched to the Select Exposure group
- The primary outcome measure will be to observe changes in the TBI Common Data Elements over time. [ Time Frame: 30, 90, 180 days post injury, then annually out to 5 years. ]See NINDS Common Data Elements for TBI
- Changes in other clinical phenotyping measures over time [ Time Frame: 30, 90, 180 days post injury, then annually out to 5 years. ]Comprehensive clinical phenotyping assessments
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
|Contact: Andre J Van Der Merwe||(301) firstname.lastname@example.org|
|Contact: Leighton Chan, M.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Leighton Chan, M.D.||National Institutes of Health Clinical Center (CC)|