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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Device: MRI imaging exam

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.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Walter Reed National Military Medical Center
  • Virginia
    • Fort Belvoir, Virginia, United States, 22060
      • Fort Belvoir Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

DoD beneficiary population

Description

Inclusion Criteria:

• Group A (acute mTBI) Adult (ages 18-55 years) any gender, who is capable of giving informed consent, having neurocognitive testing and questionnaires, able to undergo MRI, and willing to attend at least 3 of the 5 proposed clinic visits at WRNMMC.

  • Has a mild traumatic brain injury for which the individual sought medical attention in an ED/acute care clinic within 72 hours of injury.
  • Diagnosis of mTBI Acute injury and able to enroll in the study within 11 days from injury.

• Group B (Control) Adult (18 to 55 years), any gender, who is capable of undergoing informed consent, having neurocognitive testing and questionnaires, able to undergo MRI, and able to go to WRNMMC for imaging.

  • Has not had a mild traumatic brain injury in the last 5 years or ever.

• Group C (chronic mTBI) Adult (18 to 55 years), any gender, who is able to undergo MRI, and able to go to WRNMMC for imaging, capable of giving informed consent, and having neurocognitive testing and questionnaires.

  • Injury greater than 6 months but fewer than 5 years ago.

Exclusion Criteria:

• Groups A,B,C: Patients with contraindication to MRI (per standard WRNMMC SOP these individuals will not be scanned anyway. Standard WRNMMC MR screening criteria will be used as a part of their normal MR examination- e.g. non-FDA approved pacemakers, aneurysm clips,MR contraindicated metal/metallic devices, etc.).
• Groups A,B,C: Never had a penetrating, moderate or severe TBI at any time.
• Groups A,B,C: Unable to tolerate proposed imaging (e.g. severe claustrophobia, unable to tolerate lying flat for duration of MRI).
• Groups A,B,C: History of pre-existing neurologic condition which would affect the ability to interpret MRI results (such as prior stroke, multiple sclerosis, or brain tumor).
• Groups A,B,C: Patients requiring anesthesia support for sedation
• Groups A,B,C: Pregnant patients
• Groups A,B,C: Any person who is unable to sign/give consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A: Acute mTBI; Consists of up to 80 patients with acute mTBI. All acute mTBI subjects will be scanned per the HHI study design at 3 to 5 timepoints relative to their time of injury ( Visit 1 within 72 hours; Visit 2, 7 +/- 4 days; Visit 3, 30 +/- 7 days; Visit 4, 90 +/- 14 days; Visit 5, 180 +/- 30 days from injury). Even though for practicality Visits 1 and 5 are optional, every effort will be made to image as close to the time of acute injury as possible and to complete imaging for all time points.	Device: MRI imaging exam; 3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI)
B: Control; Consists of 40 age-matched participants described above who will undergo imaging twice on the MAGNUS 3.0T MRI scanner at two distinct time points. The 2 MRI imaging sessions will be at least 2 weeks apart. One of the 2 visits will include a clinical MRI scan using the same MRI acquisition protocols used for Group A. Because age-matched Controls are not expected to exhibit structural and functional changes during the study period, it was not deemed necessary for the interval between scan-visit time points to be identical for all participants in Group B.	Device: MRI imaging exam; 3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI)
C: Chronic mTBI; Consists of 40 age-matched participants with chronic mTBI (≥6 months and <5 years from mTBI injury to enrollment). Participants in this group will have 1 set of procedures at the Baseline Visit. This cohort will be used to understand functional and structural changes in chronic mTBI patients to identify indications of progression of patients from the acute to chronic phase	Device: MRI imaging exam; 3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. To identify objective imaging biomarkers (distinctive imaging findings) that are indicative of acute mTBI using the proposed advanced MAGNUS 3T MRI system designed for brain assessment	Imaging biomarkers identified on MAGNUS MRI in patients with acute mTBI	6 months
2. To identify novel and/or improved imaging biomarkers in patients with chronic mTBI (≥6 months) using the MAGNUS 3T MRI system	Imaging biomarkers on MAGNUS MRI in patients with chronic mTBI	Up to 5 days
3. To compare images from the MAGNUS 3T MRI system to the convention 750 3T MRI system	Imaging biomarkers identified on MAGNUS MRI but not on traditional MRI imaging exam	Up to 2 weeks

Collaborators and Investigators

• Sponsor: The Geneva Foundation
• Collaborators: General Electric; Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Thomas K Foo, PhD, General Electric Research

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Actual): October 31, 2022
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: MRI; mTBI; DTI; Enhanced; MR; Gradients
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 11123-0001-0001-0206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No