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

NCT05101239 | Active Not Recruiting FDA Device

• 1 other identifier: 11123-0001-0001-0206
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Traumatic Brain Injury

Keywords

MRI; DTI; Enhanced; MR; Gradients; mTBI

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

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

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

Interventions

MRI imaging exam DEVICE

3T MRI scan using with ultra high performance gradient subsystem (MAGNUS MRI)

A: Acute mTBI; B: Control; C: Chronic mTBI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

DoD beneficiary population

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Geneva Foundation: lead
• General Electric: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Thomas K Foo, PhD

  General Electric Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Department of Radiology

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 1, 2021
• Study Start: November 8, 2019
• Primary Completion: October 31, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (2)