Irvine, California 92697


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.


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.


Study is Available At:


Original ID:

HS#2003-3139


NCT ID:

NCT00580918


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Joseph C Wu, M.D.
Principal Investigator
University of California, Irvine
Primary Contact:Joseph C Wu, M.D.
949-824-7867
jcwu@uci.edu

Study Dates

Start Date:October 2003
Completion Date:January 2018
Completion Type:Anticipated
Primary Completion Date:January 2018
Primary Completion Type:Anticipated
Verification Date:October 2010
Last Changed Date:October 14, 2010
First Received Date:December 21, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:fMRI scans
Time Frame:three to four years post injury
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:functional magnetic resonance imaging fMRI
Description:functional magnetic resonance imaging fMRI
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Mild Traumatic Brain Injury group
Study Arm Type:Other
Arm Name:2
Description:Normal healthy control group

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine

Samples and Retentions

Study Population: Mild Traumatic Brain Injury Normal health controls
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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