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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00580918
• Other study ID #: HS#2003-3139
• Status: Withdrawn
• Start date: October 2003
• Est. completion date: October 2003

Study information

• Verified date: January 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Other:
• functional magnetic resonance imaging fMRI
functional magnetic resonance imaging fMRI

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI scans		three to four years post injury