Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Mclean Hospital
Sponsor:
Information provided by (Responsible Party):
William Killgore, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01803048
First received: February 27, 2013
Last updated: May 23, 2013
Last verified: May 2013
  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 Mclean Hospital:

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

Contacts
Contact: Maia Kipman 617-855-2239 mkipman@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Maia Kipman    617-855-2239      
Principal Investigator: William D Killgore, Ph.D.         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: William D Killgore, Ph.D. Mclean Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: William Killgore, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01803048     History of Changes
Other Study ID Numbers: 11040198
Study First Received: February 27, 2013
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Traumatic Brain Injury
Diffusion Weighted Imaging
Resting State Functional Connectivity
Cognition

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

ClinicalTrials.gov processed this record on July 29, 2014