We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected 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: NCT01132937
Recruitment Status : Recruiting
First Posted : May 28, 2010
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- 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 MRI results of individuals who have recently had head injury and suspected traumatic brain injury.
  • To study the natural evolution of traumatic brain injury for up to 3 months after head injury.


- Individuals at least 18 years of age who have been admitted to a hospital with a diagnosed or suspected traumatic brain injury within the past 48 hours.


  • Participants will have one 3-hour study visits: an initial visit (within 48 hours of head injury). Participants may be asked to have an optional 4-day, 30-day, 90-day, and 1-year follow-up.
  • Each visit may involve blood samples, an MRI scan (approximately 30 minutes), and a series of tests to evaluate brain function.
  • At the optional follow-up visit, participants may have blood samples, an MRI scan, and a general traumatic brain injury assessment.
  • 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

Detailed Description:


To generate natural history data for cohort-based comparisons to serve as the basis for future hypothesis-driven protocols and to contribute to the clinical and physiological understanding of traumatic brain injury (TBI) through the description of manifestations of the injury and the relationship among radiological, hematological, clinical variables and standard functional outcome measures.

Study Population

One thousand male and female adult subjects with history of recent head injury with or suspected non-penetrating acute TBI, will be enrolled. Subjects having varying degrees of TBI severity will be recruited from the collaborative programs between NIH and non-NIH hospitals. We anticipate approximately 80% of subjects will be classified as mild TBI, concussion, or no injury, with approximately two thirds of those subjects enrolled being discharged directly from the emergency department.


This is a prospective cohort study of subjects with known and suspected non-penetrating acute traumatic brain injury. Subjects presenting to the emergency department or trauma service at participating hospitals with a history of recent head injury will be studied during the course of their hospital stay and after discharge using radiological, hematological, clinical and functional outcome measures. Subjects will be stratified according to findings into cohorts for comparison. The design is intentionally broad in scope to allow acquisition of initial data for the development of future hypothesis-driven protocols. Research performed under this protocol will not interfere with standard of care and subjects will not be treated with experimental therapies as part of the research study. Data collected under this research study may be shared without personal identifiers with other researchers if subjects approve this option on the informed consent.

Outcome Measures

A variety of outcome measures will be used including diagnosis, evidence of injury on magnetic resonance imaging (MRI) and positron emission tomography (PET), functional impairment, and quality of life (QOL) assessments. The initial research questions will focus on a positive diagnosis of brain injury and monitoring the natural history. Statistical analysis plans will be developed as specific research questions and hypotheses are generated.

Study Design

Study Type : Observational
Estimated Enrollment : 1020 participants
Time Perspective: Prospective
Official Title: Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury
Study Start Date : July 1, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Evidence of injury on MRI of the brain vasculature. Qualitative observations and quantitative measures will be reported and described in relation to history, baseline clinical variables, cognitive impairment, cognitive decline and TBI outcome s...

Secondary Outcome Measures :
  1. Cognitive impairment or decline; success/failure rate for acute MRI in relationship to attempted and those able to undergo CT; imaging findings on CT in comparison to that of MRI; Neurocognitive testing and TBI Outcome Scales.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Suspected TBI Subjects

Suspected TBI subjects must meet the following inclusion criteria:

  1. History of acute head injury with or suspected non-penetrating acute TBI
  2. Age 18 years or older
  3. Deemed medically safe for study participation by the subject s attending physician
  4. Able to provide consent or have a legally-authorized representative provide consent.

Healthy Volunteers

Healthy volunteers must meet the following inclusion criteria:

  1. Healthy without past or present history of TBI or other brain disease, as evaluated by medical history and physical exam
  2. Age 18 or older.
  3. Able to provide informed consent


Suspected TBI Subjects

Suspected TBI subjects are not eligible for participation in this research study if any of the following conditions exist:

  1. Considered to be psychiatrically unstable by the patient s attending physician
  2. Contraindication to MRI scanning including: pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments.
  3. Conditions precluding entry into the scanner such as morbid obesity or claustrophobia or conditions requiring sedation.
  4. In female subjects, pregnancy.

Healthy Volunteers

Healthy volunteers are not eligible for participation in this research study if any of the following conditions exist:

  1. Presence of cognitive impairment based on medical history and/or Mini Mental State Examination (MMSE) score of < 27
  2. Current or past DSM-IV diagnosis of a psychiatric disorder including substance use disorder as determined by self-report, medical history, and/or clinical exam
  3. Major medical problems that can impact brain function (e.g., problems of the CNS including seizures and psychosis; cardiovascular disease including hypertension and arrhythmias; metabolic, autoimmune, endocrine disorders) as determined by self-report, medical history and/or clinical exam;
  4. 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 subject 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 subject s eyes).
  5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
  6. In female subjects, pregnancy or breastfeeding.
  7. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
Contacts and Locations

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): NCT01132937

Contact: Martin R Cota, CCRC (301) 435-1929 cotamr2@mail.nih.gov
Contact: Lawrence Latour, Ph.D. (301) 496-0463 latourl@ninds.nih.gov

United States, District of Columbia
Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
United States, Maryland
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Center for Neuroscience and Regenerative Medicine (CNRM)
United States Department of Defense
Henry M. Jackson Foundation for the Advancement of Military Medicine
Principal Investigator: Lawrence Latour, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
More Information

Additional Information:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01132937     History of Changes
Other Study ID Numbers: 100122
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 10, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Magnetic Resonance Imaging (MRI)
Traumatic Brain Injury
Brain Imaging
Brain Injuries

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