Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quantitative Automated Lesion Detection of Traumatic Brain Injury (QALD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01022307
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease
Traumatic Brain Injury

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 212 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Quantitative Automated Lesion Detection of TBI
Study Start Date : May 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Biospecimen Retention:   None Retained
No biospecimen, only digital data.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022307


Locations
Layout table for location information
United States, California
VA Northern California HCS
Martinez, California, United States, 94553
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: David L. Woods, PhD VA Northern California HCS

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022307     History of Changes
Other Study ID Numbers: B6120-R
First Posted: December 1, 2009    Key Record Dates
Results First Posted: January 14, 2016
Last Update Posted: January 14, 2016
Last Verified: December 2015

Keywords provided by VA Office of Research and Development:
behavioral data acquisition
MRI

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