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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia C Maly Sundgren, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00760903
First received: September 24, 2008
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Brain Trauma
Other: Conventional MRI of the brain
Other: MR spectroscopy (MRS)
Other: MR Diffusion Tensor Imaging (DTI)

Study Type: Observational
Study Design: Observational Model: Case Control

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: June 2003
Study Completion Date: September 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
> 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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760903

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Pia C Maly Sundgren, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00760903     History of Changes
Other Study ID Numbers: 2003-0053
Study First Received: September 24, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Moderate brain trauma

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on November 25, 2014