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Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

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ClinicalTrials.gov Identifier: NCT01803048
Recruitment Status : Recruiting
First Posted : March 4, 2013
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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. 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 or disease
Traumatic Brain Injury

Study Design

Study Type : Observational
Estimated Enrollment : 180 participants
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
Actual Study Start Date : February 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Diffusion Weighted Imaging Metric: fractional anisotropy (FA) [ Time Frame: Measured on the day of the MRI scan ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803048


Contacts
Contact: Simone Hyman simonehyman@psychiatry.arizona.edu
Contact: Melissa Gottschlich melgottschlich@psychiatry.arizona.edu

Locations
United States, Arizona
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Simone Hyman       simonehyman@psychiatry.arizona.edu   
Contact: Melissa Gottschlich       melgottschlich@psychiatry.arizona.edu   
Principal Investigator: William D Killgore, Ph.D.         
Sponsors and Collaborators
University of Arizona
United States Department of Defense
Investigators
Principal Investigator: William D Killgore, Ph.D. University of Arizona
More Information

Responsible Party: William D. Killgore, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT01803048     History of Changes
Other Study ID Numbers: 1407388572
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by William D. Killgore, University of Arizona:
Traumatic Brain Injury
Diffusion Weighted Imaging
Resting State Functional Connectivity
Cognition

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