Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

NCT01803048 | Completed

• 1 other identifier: 1407388572
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Diffusion Weighted Imaging; Resting State Functional Connectivity; Cognition

Outcome Measures

Primary Outcomes (1)

• Diffusion Weighted Imaging Metric: fractional anisotropy (FA)

  Measured on the day of the MRI scan

Study Arms (2)

TBI

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

30 healthy individuals with no history of TBI

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

One hundred eighty participants aged 20-45, including 150 adults with documented mild TBI and 30 healthy controls (HC) will participate in this study. Participants in the TBI group will include 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; and 30 individuals who will be tested at 12 months post-TBI. Participants will be recruited from the local area of Boston, MA, via IRB-approved flyers and advertisements placed in newspapers, on the radio and within vehicles of the local public transport system (e.g. buses and subway cars).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Arizona Psychiatry Department

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• William D Killgore, Ph.D.

  University of Arizona Psychiatry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)