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NCT01132898 · ClinicalTrials.gov registry record
Long-term Clinical Correlates of Traumatic Brain Injury
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- 354
- Enrollment target
NCT01132898: Clinical Trial study, sponsored by National Institutes of Health Clinical Center (CC).
NCT01132898 is a clinical trial that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 354 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132898 was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- 354 participants
- Enrollment target
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.
Primary Outcome
See NINDS Common Data Elements for TBI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2011-03-31 |
| Est. Completion | 2024-08-27 |
Why NCT01132898 stopped before completion
NCT01132898 is an observational study that tracks outcomes without assigning an intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01132898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01132898 about?
NCT01132898 is a clinical study titled "Long-term Clinical Correlates of Traumatic Brain Injury". 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 i...
What is the current status of trial NCT01132898?
This trial is currently terminated. The enrollment target is 354 participants. The study started on 2011-03-31. Estimated completion is 2024-08-27.
Who is sponsoring clinical trial NCT01132898?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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