NCT05101239

Acute and Mild TBI Injury in Military and Civilian Population Using Advanced MR Imaging

Acute and Mild Traumatic Brain Injury in a Military (and Civilian) Population Using Advanced Microstructure Imaging in Novel Ultra-High Performance MRI

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: The Geneva Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a prospective longitudinal study of patients with acute mTBI and comparison with chronic mTBI patients and a cohort without history of TBI or none within 5 years of enrollment. The patients will be recruited from the eligible population at military medical centers in the National Capital Region.

Detailed description

All patients seen with suspected mTBI will undergo standard TBI assessment per institutional standard operating procedure. Mild TBI will be defined by Department of Defense/Department of Veterans Affairs Consensus- based Classification of Closed TBI Severity. This project will leverage several existing TBI clinics/programs and benefits from the clinical and technical knowledge gained from each. All participants will undergo the same screening, eligibility assessment, informed consent, baseline history/physical, statement of negative pregnancy status (if applicable), survey questionnaires, VOMS, BESS, King-Devick and abbreviated neurocognitive testing once. Participants will undergo research MRI twice at time points \> 2 weeks apart and one clinical MRI. Blood samples will be collected at each study visit. The research blood specimens will be processed immediately, frozen and sent to the WRNMMC Research Laboratory for future biomarker and genomic analysis. MRI imaging findings (common data elements or newer imaging biomarkers discovered during the initial two-year technical development phase) will be analyzed to determine the most relevant biomarkers indicative of mTBI injury and/or prognosis for recovery. More advanced correlation analysis and relative risk regression will be performed to correlate mTBI and PTSD and their comorbid associations (e.g., depression, anxiety), Statistical tests will be corrected for multiple comparisons as appropriate.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	MRI imaging exam	3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI)

Timeline

• Start date: 2019-11-08
• Primary completion: 2022-10-31
• Completion: 2026-06-30
• First posted: 2021-11-01
• Last updated: 2023-09-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study