Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

This study has suspended participant recruitment.
(Currently in the middle of transferring the study from one location to another.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William D. Killgore, University of Arizona
ClinicalTrials.gov Identifier:
NCT01803048
First received: February 27, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.

Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Model for Predicting Cognitive and Emotional Health From Structural and Functional Neurocircuitry Following Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Diffusion Weighted Imaging Metric: fractional anisotropy (FA) [ Time Frame: Measured on the day of the MRI scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: February 2013
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

Inclusion Criteria:

  • English as first language
  • Ability to provide informed consent
  • Right handedness
  • 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)
  • Left or mixed handedness
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803048

Locations
United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: William D Killgore, Ph.D. University of Arizona
  More Information

No publications provided

Responsible Party: William D. Killgore, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT01803048     History of Changes
Other Study ID Numbers: 1407388572
Study First Received: February 27, 2013
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Traumatic Brain Injury
Diffusion Weighted Imaging
Resting State Functional Connectivity
Cognition

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on April 27, 2015