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NCT00724607 · ClinicalTrials.gov registry record
Brain Injury Outcomes (BIO) Study
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 91
- Enrollment target
NCT00724607: Completed study, sponsored by VA Office of Research and Development.
NCT00724607 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 91 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00724607 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 91 participants
- Enrollment target
Study Summary
Many active duty military, national guard, and reserves personnel who served in the recent conflicts in Afghanistan and Iraq were exposed to blasts and other mechanisms of traumatic brain injury (TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after head injury, particularly blast-related, has become a common occurrence only in recent decades. As such, the associated cerebral damage is less well studied and understood, particularly over the long term. The Brain Injury Outcomes (BIO) is a longitudinal study with the short-term objective of better characterizing multi-modal outcomes in individuals who have sustained a brain injury using a systems medicine approach. Long-term aims include monitoring participants for signs of emerging symptoms or age-related vulnerabilities. Identification of abnormality profiles for multiple severity levels of brain injury (from any source, including blast and non-blast) reflects a second long-range goal. Third, the investigators will examine and compare physiology between Veterans who have sustained a Mild Traumatic Brain Injury (mTBI) with and without persisting symptoms and various co-morbidities including posttraumatic stress disorder (PTSD) and depression. A control group of Veterans who have not sustained a TBI will also be recruited for comparison. Fourth, the investigators intend to facilitate the clinical use of advanced methodologies, such as brain imaging measures, with the brain injured (and other populations). Finally, the investigators will assess methods of analysis, separately and in combination through integration, for multi-modal data in search of diagnostic profiles. Increased knowledge of injury patterns and the trajectory associated with brain injury could contribute to better methods of diagnosis, monitoring and, perhaps, treatment. This investigation has spawned several sub-studies, one of which was the Validation of Brief Objective Neurobehavioral Detectors (BOND) of Mild TBI,
Primary Outcome
In this longitudinal study with multiple measurement modalities (i.e., neuroimaging, neurologic exam, cognition, etc.), the primary outcome measures are from the neuroimaging modality, specifically, the diffusion tensor imaging (DTI) sequences. FA is one of the quantitative metrics yielded by the DTI sequence. FA is a ratio of the directional flows of water molecules within axonal bundles and is interpreted as a representation of the overall structural health of the bundle.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2008-05-06 |
| Est. Completion | 2024-01-15 |
What the finished NCT00724607 record still lists
NCT00724607 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 91 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00724607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00724607 about?
NCT00724607 is a clinical study titled "Brain Injury Outcomes (BIO) Study". Many active duty military, national guard, and reserves personnel who served in the recent conflicts in Afghanistan and Iraq were exposed to blasts and other mechanisms of traumatic brain injury (TBI).1,2 Although physical trauma is not unexpected during war fighting, survival after head injury, par...
What is the current status of trial NCT00724607?
This trial is currently completed. The enrollment target is 91 participants. The study started on 2008-05-06. Estimated completion is 2024-01-15.
Who is sponsoring clinical trial NCT00724607?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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