Mild Traumatic Brain InjuryNCT05101239
Acute and Mild TBI Injury in Military and Civilian Population Using Advanced MR Imaging
An observational study of Mild Traumatic Brain Injury, run by The Geneva Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- MRI imaging exam
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2019to 30 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: DoD beneficiary population
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
Official title: 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.
Read the 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
- Being tested
- MRI imaging exam
- Keywords
- MRI, DTI, Enhanced, MR, Gradients, mTBI
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI imaging examDevice
3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI imaging exam | |
| 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. Receives: Device: MRI imaging exam | |
| 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 Receives: Device: MRI imaging exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start8 Nov 2019
- Primary completion31 Oct 2022
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Vincent B Ho, Walter Reed National Military Medical Center
- Investigators
- Thomas K Foo, PhD, Principal investigator, General Electric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101239
- Sponsor's protocol ID
- 11123-0001-0001-0206
- Status last verified
- Sep 2023
- First submitted
- 14 Oct 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Mild Traumatic Brain Injury in a Military (and Civilian) Population Using Advanced Microstructure Imaging in Novel Ultra-High Performance MRI
- ClinicalTrials.gov ID
- NCT05101239
- Acronym / sponsor ID
- 11123-0001-0001-0206
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- MRI, DTI, Enhanced, MR, Gradients, mTBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- General Electric, Congressionally Directed Medical Research Programs
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Acute mTBI | – | Device: MRI imaging examConsists 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. |
| B: Control | – | Device: MRI imaging examConsists 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. |
| C: Chronic mTBI | – | Device: MRI imaging examConsists 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- DoD beneficiary population
Key inclusion criteria (7 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI imaging exam3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI) | Device | A: Acute mTBI, B: Control, C: Chronic mTBI |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas K Foo, PhD principal investigator
General Electric Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by The Geneva Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.