Functional MRI Study of Attention in Normal Controls and... | NCT00580918

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

NCT00580918

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Jan 25, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Mild Traumatic Brain Injury

Interventions

functional magnetic resonance imaging fMRI

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Nonapplicable clinical trial

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Oct 2003Actual

Completion Date

Oct 2003Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Mild Traumatic Brain Injury group	Other: functional magnetic resonance imaging fMRI
2		Normal healthy control group	Other: functional magnetic resonance imaging fMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
functional magnetic resonance imaging fMRI	Other	functional magnetic resonance imaging fMRI	1 2

Measure	Description	Time Frame
fMRI scans		three to four years post injury

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Mild Traumatic Brain Injury Normal health controls

Sampling Method

Non-Probability Sample

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases