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

This study is currently recruiting participants.

Verified by University of California, Irvine, November 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00580918

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.

Condition	Intervention
Mild Traumatic Brain Injury	Other: functional magnetic resonance imaging fMRI

MedlinePlus related topics: MRI Scans Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

fMRI scans [ Time Frame: three to four years post injury ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	October 2003
Estimated Study Completion Date:	January 2018
Estimated Primary Completion Date:	January 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Mild Traumatic Brain Injury group	Other: functional magnetic resonance imaging fMRI functional magnetic resonance imaging fMRI
2 Normal healthy control group	Other: functional magnetic resonance imaging fMRI functional magnetic resonance imaging fMRI

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Mild Traumatic Brain Injury Normal health controls

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580918

Contacts

Contact: Joseph C Wu, M.D.

949-824-7867

jcwu@uci.edu

Locations

United States, California
University of California, Irvine	Recruiting
Irvine, California, United States, 92697
Contact: Joseph C Wu, M.D. 949-824-7867 jcwu@uci.edu
Sub-Investigator: Orhan Nalcioglu, Ph.D.
Sub-Investigator: Tugan Muftuler, Ph.D.
Sub-Investigator: Paul Rodriguez
Sub-Investigator: Carol Schachat, M.A.

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Joseph C Wu, M.D.

University of California, Irvine

More Information

Responsible Party:	University of California, Irvine ( Joseph C. Wu, M. D. , Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center )
Study ID Numbers:	HS#2003-3139
Study First Received:	December 21, 2007
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00580918
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Mild Traumatic Brain Injury
fMRI

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009