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

NCT00580918 | Withdrawn

• 1 other identifier: HS#2003-3139
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury; fMRI

Outcome Measures

Primary Outcomes (1)

• fMRI scans

  three to four years post injury

Study Arms (2)

1

Mild Traumatic Brain Injury group

Other: functional magnetic resonance imaging fMRI

2

Normal healthy control group

Other: functional magnetic resonance imaging fMRI

Interventions

functional magnetic resonance imaging fMRI OTHER

functional magnetic resonance imaging fMRI

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mild Traumatic Brain Injury Normal health controls

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Joseph C Wu, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: October 1, 2003
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)