MedPath

Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma

Withdrawn
Conditions
Brain Trauma
Interventions
Other: Conventional MRI of the brain
Other: MR spectroscopy (MRS)
Other: MR Diffusion Tensor Imaging (DTI)
Registration Number
NCT00760903
Lead Sponsor
University of Michigan
Brief Summary

The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies.

By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome.

Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date.

By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery.

Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.

Detailed Description

The purpose of this study is to determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. This study may show that MRI can provide a clearer picture on the extent of the brain injury and help medical physicians decide how to best treat these patients with a more accurate idea of the brain function of the recovering patient.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Patients of acute moderate brain trauma
Exclusion Criteria
  • Patients who are medically unstable or have CT findings that may interfere with the study such as:

    • a large hemorrhage or edema
    • encephalomalacia
    • prior neurosurgeries
    • hardware placed in the head or neck
    • prior head trauma
    • history of neurological conditions

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
> 18, gender and race indifferentMR Diffusion Tensor Imaging (DTI)Group II: 30 patients \> 18 years old, gender, and race indifferent with moderate head trauma
Control GroupConventional MRI of the brainGroup V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems.
Control GroupMR Diffusion Tensor Imaging (DTI)Group V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems.
> 18 years moderate head traumaMR Diffusion Tensor Imaging (DTI)Group I: (Pilot group): 5-10 patients \> 18 years old, gender and race indifferent with moderate head trauma.
> 18, gender and race indifferentConventional MRI of the brainGroup II: 30 patients \> 18 years old, gender, and race indifferent with moderate head trauma
Control GroupMR spectroscopy (MRS)Group V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems.
> 18, gender and race indifferentMR spectroscopy (MRS)Group II: 30 patients \> 18 years old, gender, and race indifferent with moderate head trauma
PediatricConventional MRI of the brainGroup III: 30 patients \< 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group)
PediatricMR Diffusion Tensor Imaging (DTI)Group III: 30 patients \< 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group)
Pre-evaluatedConventional MRI of the brainGroup IV: 10-20 patients age, gender and race indifferent with moderate head trauma that have been examined with conventional MRI of the brain, MRS and DTI as clinically requested. The images of these patients will be evaluated retrospectively for data- point collection.
Pre-evaluatedMR spectroscopy (MRS)Group IV: 10-20 patients age, gender and race indifferent with moderate head trauma that have been examined with conventional MRI of the brain, MRS and DTI as clinically requested. The images of these patients will be evaluated retrospectively for data- point collection.
PediatricMR spectroscopy (MRS)Group III: 30 patients \< 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group)
> 18 years moderate head traumaConventional MRI of the brainGroup I: (Pilot group): 5-10 patients \> 18 years old, gender and race indifferent with moderate head trauma.
> 18 years moderate head traumaMR spectroscopy (MRS)Group I: (Pilot group): 5-10 patients \> 18 years old, gender and race indifferent with moderate head trauma.
Pre-evaluatedMR Diffusion Tensor Imaging (DTI)Group IV: 10-20 patients age, gender and race indifferent with moderate head trauma that have been examined with conventional MRI of the brain, MRS and DTI as clinically requested. The images of these patients will be evaluated retrospectively for data- point collection.
Primary Outcome Measures
NameTimeMethod
To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury.1 year
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

© Copyright 2025. All Rights Reserved by MedPath