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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.3 years study duration

Study Start

First participant enrolled

June 1, 2003

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed

Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

5.3 years

First QC Date

September 24, 2008

Last Update Submit

January 4, 2017

Conditions

Brain Trauma

Keywords

Moderate brain trauma

Outcome Measures

Primary Outcomes (1)

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

Study Arms (5)

> 18 years moderate head trauma

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