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Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients

This study is currently recruiting participants.
Verified October 2010 by University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580918
First Posted: December 27, 2007
Last Update Posted: October 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
University of California, Irvine
  Purpose
The purpose of this study will be to assess the attentional ability of patients with mild to moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI) technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of activation with those of normal controls to see if there is a failure to activate frontal lobes in the traumatic brain injured subjects.

Condition Intervention
Mild Traumatic Brain Injury Other: functional magnetic resonance imaging fMRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • fMRI scans [ Time Frame: three to four years post injury ]

Estimated Enrollment: 40
Study Start Date: October 2003
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Mild Traumatic Brain Injury group
Other: functional magnetic resonance imaging fMRI
functional magnetic resonance imaging fMRI
2
Normal healthy control group
Other: functional magnetic resonance imaging fMRI
functional magnetic resonance imaging fMRI

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Mild Traumatic Brain Injury Normal health controls
Criteria

Inclusion Criteria:

  • Mild to moderate brain injury patients referred to the UCI Brain Imaging Center.

    • Mild brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 13-15.
    • Moderate brain injury brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 9-12 .
  • Normal healthy control subjects (20)

Exclusion Criteria:

  • Pre-accident neuropathology, psychopathology, or secondary neuropathological complications, or chemical abuse
  • Patients who required intracranial surgical intervention
  • Children, pregnant women, or institutionalized individuals unable to freely give consent
  • Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material
  • Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities
  • Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported)
  • Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion
  • Patients with implanted prosthetic heart valves
  • Patients with pacemakers, neuro-stimulation devices
  • Subjects who have severe claustrophobia.
  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): NCT00580918


Contacts
Contact: Joseph C Wu, M.D. 949-824-7867 jcwu@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Joseph C Wu, M.D.    949-824-7867    jcwu@uci.edu   
Sub-Investigator: Orhan Nalcioglu, Ph.D.         
Sub-Investigator: Tugan Muftuler, Ph.D.         
Sub-Investigator: Paul Rodriguez         
Sub-Investigator: Carol Schachat, M.A.         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Joseph C Wu, M.D. University of California, Irvine
  More Information

Responsible Party: Joseph C. Wu, M. D. , Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00580918     History of Changes
Other Study ID Numbers: HS#2003-3139
First Submitted: December 21, 2007
First Posted: December 27, 2007
Last Update Posted: October 15, 2010
Last Verified: October 2010

Keywords provided by University of California, Irvine:
Mild Traumatic Brain Injury
fMRI

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