Quantitative Automated Lesion Detection of Traumatic Brain Injury (QALD)

December 8, 2015 updated by: VA Office of Research and Development

Quantitative Automated Lesion Detection of TBI

The investigators propose to develop quantitative automated lesion detection (QALD) procedures to identify brain damage following traumatic brain injury more accurately than is possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about 1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive tests. The investigators will compare the results of the cognitive tests with those from MRI scanning to determine what brain regions are responsible for superior performance and for performance decrements.

Study Overview

Status

Completed

Conditions

Detailed Description

Because of their non-focal nature, TBI-related brain lesions are difficult to detect and quantify with traditional MRI. In the current research program the investigators propose to develop quantitative automated lesion detection (QALD) procedures to (1) clarify the nature and distribution of tissue damage following mild, moderate and severe TBI (2) improve the capability of detecting, quantifying, and localizing TBI brain damage in individual patients and (3) correlate quantitative measures of brain damage in individual TBI patients with neuropsychological deficits in attention, memory, and executive function.

QALD detects abnormal tissue parameters in the diseased brain through statistical comparisons with a normative database. Preliminary results show that QALD is capable of detecting highly significant abnormalities in the brains of TBI patients with normal clinical MRI scans. QALD will be further enhanced and tested with a larger database and including brain images acquired with four different imaging sequences (T1, T2, DTI and fluid-attenuated inversion recovery or FLAIR) from 100 control subjects. Data analysis will incorporate advanced cortical surface mapping techniques to quantify gray matter tissue parameters and thickness in 34 distinct cortical regions in each hemisphere. In addition, cortical fiber projections will be quantified with DTI and FLAIR analysis of white matter lying below the cortical surface. Subcortical fiber tracts critical for complex cognitive operations will be analyzed with voxel-based morphometry and with improved region of interest algorithms to define fiber tract boundaries. Tissue properties in critical subcortical structures (e.g., the hippocampus) will be quantified after automatic parcellation of these brain regions. The investigators will also test the control subjects on a battery of neuropsychological tests (NPTs) and correlate variations in the size, myelination, and tissue properties of normal cortical and subcortical structures with cognitive performance. Then, the investigators will gather identical imaging data in 99 TBI patients divided into three groups (mild, moderate and severe TBI) in order to characterize the average pattern of damage caused by TBIs of different severity. Next, the investigators will quantify lesions in individual TBI patients and describe the variability of lesion patterns in the different severity groups. In parallel, the investigators will develop further multimodal analysis techniques to combine statistical information from different imaging sequences to improve lesion-detection sensitivity to co-localized abnormalities evident with different imaging protocols. In addition, the investigators will test patients with NPTs and analyze the relationship between brain damage, cognitive performance and self-assessments of outcome in order to improve the prognostic value of neuroradiological studies of TBI.

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Martinez, California, United States, 94553
        • VA Northern California HCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Our targeted population is veterans from OEF/OIF. Other subjects will be recruited as needed to fulfill recruitment targets.

Description

Inclusion Criteria:

  • Control subjects from 18-50.
  • Patients from 18-50 who have suffered TBI.

Exclusion Criteria:

  • Substance abuse.
  • Irremedial sensory deficits (blindness, deafness).
  • Primary psychiatric disorder.
  • Neurological disease unrelated to TBI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1: no history of TBI
184 participants with no history of traumatic brain injury (TBI).
Group 2: with a history of TBI
28 patients with a history of TBI. Most of these patients had suffered mild TBI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance on Trail-making Test, Part B
Time Frame: Single session generally several years after TBI depending on time of recruitment of subjects.
z-score based on response time, regressed for age and computer use
Single session generally several years after TBI depending on time of recruitment of subjects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B6120-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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