Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI
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|ClinicalTrials.gov Identifier: NCT01803048|
Recruitment Status : Recruiting
First Posted : March 4, 2013
Last Update Posted : July 26, 2018
Abnormalities in structural and functional connectivity between brain regions have been suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant contributors to neuropsychological functioning and injury outcome. The purpose of this study is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted imaging (DWI) and resting state functional MRI to compare structural and functional connectivity between individuals with documented mild TBI and healthy controls. To evaluate the significance of structural and functional connectivity for behavior, the brain imaging data will then be related to measures of cognition and emotion. Over a 4-year period, 150 adults with documented mild TBI and 30 healthy controls will participate in the study.
The study will investigate the following questions and hypotheses:
- Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter integrity across multiple stages of recovery following mild TBI relative to healthy controls. It is hypothesized that mild TBI will be associated with greater white matter abnormalities than healthy controls.
- It is hypothesized that there will be a relationship between FA, cognition and emotion as a function of the injury.
- It is hypothesized that functional connectivity will be related to FA.
|Condition or disease|
|Traumatic Brain Injury|
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Official Title:||A Model for Predicting Cognitive and Emotional Health From Structural and Functional Neurocircuitry Following Traumatic Brain Injury|
|Actual Study Start Date :||February 2013|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
30 individuals who will be tested at two weeks post-TBI; 30 individuals who will be tested at one month post-TBI; 30 individuals who will be tested at three months post-TBI; 30 individuals who will be tested at six months post-TBI; 30 individuals who will be tested at 12 months post-TBI.
30 healthy individuals with no history of TBI
- Diffusion Weighted Imaging Metric: fractional anisotropy (FA) [ Time Frame: Measured on the day of the MRI scan ]
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): NCT01803048
|Contact: Brittany Forbeckemail@example.com|
|Contact: Michael Strongfirstname.lastname@example.org|
|United States, Arizona|
|University of Arizona Medical Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Brittany Forbeck email@example.com|
|Contact: Anna Sanova firstname.lastname@example.org|
|Principal Investigator: William D Killgore, Ph.D.|
|Principal Investigator:||William D Killgore, Ph.D.||University of Arizona|