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

NCT ID: NCT00760903

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2009-09-30

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.

Conditions

Brain Trauma

Study Design

• Observational Model Type: CASE_CONTROL

Study Groups

> 18 years moderate head trauma

Group I: (Pilot group): 5-10 patients \> 18 years old, gender and race indifferent with moderate head trauma.

Conventional MRI of the brain

Intervention Type: OTHER

MR spectroscopy (MRS)

Intervention Type: OTHER

MR Diffusion Tensor Imaging (DTI)

Intervention Type: OTHER

> 18, gender and race indifferent

Group II: 30 patients \> 18 years old, gender, and race indifferent with moderate head trauma

Conventional MRI of the brain

Intervention Type: OTHER

MR spectroscopy (MRS)

Intervention Type: OTHER

MR Diffusion Tensor Imaging (DTI)

Intervention Type: OTHER

Pediatric

Group III: 30 patients \< 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group)

Conventional MRI of the brain

Intervention Type: OTHER

MR spectroscopy (MRS)

Intervention Type: OTHER

MR Diffusion Tensor Imaging (DTI)

Intervention Type: OTHER

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.

Conventional MRI of the brain

Intervention Type: OTHER

MR spectroscopy (MRS)

Intervention Type: OTHER

MR Diffusion Tensor Imaging (DTI)

Intervention Type: OTHER

Control Group

Group V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems.

Conventional MRI of the brain

Intervention Type: OTHER

MR spectroscopy (MRS)

Intervention Type: OTHER

MR Diffusion Tensor Imaging (DTI)

Intervention Type: OTHER

Interventions

Conventional MRI of the brain

Intervention Type: OTHER

MR spectroscopy (MRS)

Intervention Type: OTHER

MR Diffusion Tensor Imaging (DTI)

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Pia C Maly Sundgren, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

2003-0053

Identifier Type: -

Identifier Source: org_study_id