Brain Injury Outcomes (BIO) Study

Dementia Clinical Trial

— BIO  

Official title:

Validation of Brief Objective Neurobehavioral Detectors of Mild TBI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00724607
• Other study ID #: SHP 08-167
• Secondary ID: 01133
• Status: Recruiting
• Start date: May 6, 2008
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2023
• Source: VA Office of Research and Development
• Contact: Julie C Chapman, PsyD
• Phone: (202) 745-8000
• Email: julie.chapman[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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 Exclusion Criteria: Exclusion Criteria for both the Case and Control Groups:

Veterans must NOT:

• be colorblind or have any visual impairment that interferes with reading or writing
• have any upper extremity dysfunction that prevents the use of a pencil or computer mouse or keyboard
• meet criteria for substance dependence within 1 month of the evaluation
• have a current acute or unstable psychiatric condition
• have a current diagnosis (or symptoms consistent with) schizophrenic or bipolar disorders, or severe uni-polar depression
• be in significant pain during the evaluation (patient subjective report)
• have a diagnosis of diabetes (PET imaging considerations)
• have had or currently have any other injury, medical or neurological illness, or exposure that could potentially explain cognitive deficits (e.g., Central Nervous System disease, prior brain injury, seizure disorder, or HIV)
• be taking prescription drugs that significantly interfere with outcome measures
• have any devices or material implanted, embedded, or attached to the body containing ferrous material that interferes with MR imaging (i.e., pacemaker, shrapnel)
• Be a pregnant or lactating female (MRI considerations)
• Display behavior that would significantly interfere with validity of data collection or safety during study

Related Conditions & MeSH terms

• Brain Concussion
• Dementia
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Johns Hopkins University, Oak Ridge National Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional anisotropy (FA)	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.	Alternating years

External Links

•   PubMed Abstract