Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803048
• Other study ID #: 1407388572
• Status: Completed
• Start date: February 2013
• Est. completion date: December 2019

Study information

• Verified date: November 2020
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	University of Arizona Psychiatry Department	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion Weighted Imaging Metric: fractional anisotropy (FA)		Measured on the day of the MRI scan