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

January 22, 2021 updated by: University of California, Irvine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mild Traumatic Brain Injury Normal health controls

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2
Normal healthy control group
Other: functional magnetic resonance imaging fMRI
functional magnetic resonance imaging fMRI
1
Mild Traumatic Brain Injury group
Other: functional magnetic resonance imaging fMRI
functional magnetic resonance imaging fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI scans
Time Frame: three to four years post injury
three to four years post injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Joseph C Wu, M.D., University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS#2003-3139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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