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Brain Injury Outcomes (BIO) Study

Validation of Brief Objective Neurobehavioral Detectors of Mild TBI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00724607
Acronym
BIO
Enrollment
91
Registered
2008-07-29
Start date
2008-05-06
Completion date
2024-01-15
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion, Dementia, Posttraumatic Stress Disorder

Keywords

Concussion, traumatic brain injury, Screening, neuroimaging, Posttraumatic stress disorder, Longitudinal studies

Brief 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, which continues. The investigators have collaborated with Harvard/Boston Children's Hospital in the Angiogenic Signaling Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory (ORNL) will assist in integrating BIO Study multi-modal data. Investigators at Johns Hopkins School of Medicine collaborate with neuroimaging sequences and methods.

Detailed description

This study was previously paused due to the pandemic. 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, which continues. The investigators have collaborated with Harvard/Boston Children's Hospital in the Angiogenic Signaling Signatures Identified in Stress and Trauma (ASSIST) sub-study. Oak Ridge National Laboratory (ORNL) will assist in integrating BIO Study multi-modal data. Investigators at Johns Hopkins School of Medicine collaborate with neuroimaging sequences and methods.

Interventions

None listed

Sponsors

Oak Ridge National Laboratory
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for TBI Group (Case Group): TBI group Veterans must: * be enrolled at the Washington, DC VA Medical Center * be an Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF)/OND Veteran * be between the ages of 18 and 59, inclusive * have at least 10 years of education * be able to fit into scanner (i.e., weigh less than 400 pounds) * have a brain injury (based upon VHA criteria) * be at least one year post-injury Inclusion criteria for NonTBI Group (Control Group): NonTBI group Veterans must: * be enrolled at the Washington, DC VAMC * have been active duty (whether deployed or not) during OEF and/or OIF and/or OND * be between the ages of 18 and 59, inclusive * have at least 10 years of education

Design outcomes

Primary

MeasureTime frameDescription
Fractional anisotropy (FA)Alternating yearsIn 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026