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

Withdrawn

• Conditions: Mild Traumatic Brain Injury
• Interventions: Other: functional magnetic resonance imaging fMRI

• Registration Number: NCT00580918
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	functional magnetic resonance imaging fMRI	Mild Traumatic Brain Injury group
2	functional magnetic resonance imaging fMRI	Normal healthy control group

Primary Outcome Measures

Name	Time	Method
fMRI scans	three to four years post injury

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States