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

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.

Study Overview

• Status: Withdrawn
• Conditions: Brain Trauma
• Intervention / Treatment: Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI)

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Have had a clinically ordered CT exam performed within 24 hours of admission to the hospital. We will be enrolling 5 different groups of subjects into this study. These groups include patients18 years of age or older with moderate to severe head trauma. Children under 18 years of age with moderate to severe head trauma. A group of patients of any age who have already undergone conventional MRI of the brain and a group of volunteers who are part of another research study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
> 18 years moderate head trauma; Group I: (Pilot group): 5-10 patients > 18 years old, gender and race indifferent with moderate head trauma.	Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI)
> 18, gender and race indifferent; Group II: 30 patients > 18 years old, gender, and race indifferent with moderate head trauma	Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI)
Pediatric; Group III: 30 patients < 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group)	Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI)
Pre-evaluated; 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.	Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI)
Control Group; Group V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems.	Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 24, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 26, 2008

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Moderate brain trauma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2003-0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO