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Long-term Clinical Correlates of Traumatic Brain Injury

NCT01132898 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 354

Last updated 2024-09-20

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 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.

Conditions

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Leighton Chan, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2024-08-27
Completion
2024-08-27

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01132898 on ClinicalTrials.gov