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

September 22, 2023 updated by: Vincent B Ho, The Geneva Foundation

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 6 months
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
Time Frame: Up to 5 days
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
Time Frame: Up to 2 weeks
Imaging biomarkers identified on MAGNUS MRI but not on traditional MRI imaging exam
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Geneva Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
General Electric
Congressionally Directed Medical Research Programs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas K Foo, PhD, General Electric Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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