Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

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:

1. 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. 2. It is hypothesized that there will be a relationship between FA, cognition and emotion as a function of the injury. 3. It is hypothesized that functional connectivity will be related to FA.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona Psychiatry Department

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

English as first language
Ability to provide informed consent
For TBI group: documented TBI experienced within 12 months prior to testing.

Exclusion criteria

Metal within the body, claustrophobia or other contraindications for MRI
Complicating medical conditions that may influence the outcome of neuropsychological assessment or neuroimaging (e.g., HIV, brain tumor, etc.)
Less than 9th grade education
History of alcoholism or substance use disorder
Excess current alcohol use or illicit substance use
for Healthy Controls (HC): life-time history of TBI or Axis I disorder
Pregnancy (ruled out by urine β-HCG)
Colorblindness
for HC: Having participated in a sport with a high risk of concussive/subconcussive blows for a period of at least 1 month including but not limited to: football, rugby, boxing, ice hockey, wrestling, soccer, martial arts

Treatment and study plan

Primary outcomes

Diffusion Weighted Imaging Metric: fractional anisotropy (FA)

Time frame: Measured on the day of the MRI scan

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

United States Department of Defense

Registry information

Official study title

A Model for Predicting Cognitive and Emotional Health From Structural and Functional Neurocircuitry Following Traumatic Brain Injury

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Mar 4, 2013
Registry last updated: Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed