Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

University of Arizona

Status: Completed

Conditions: Traumatic Brain Injury

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01803048

1407388572

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

190 participants in 2 patient groups

TBI

Description:

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.

Healthy Control

Description:

30 healthy individuals with no history of TBI