Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

NCT01132937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 886

Last updated 2026-04-29

No results posted yet for this study

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 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.

Eligibility:

\- 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.

Design:

* 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.

Conditions

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED
  • United States Department of Defense

    collaborator FED
  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    collaborator OTHER
  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Lawrence L Latour, Ph.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-07

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01132937 on ClinicalTrials.gov