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

NCT ID: NCT00580918

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2003-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Mild Traumatic Brain Injury group

functional magnetic resonance imaging fMRI

Intervention Type OTHER

functional magnetic resonance imaging fMRI

2

Normal healthy control group

functional magnetic resonance imaging fMRI

Intervention Type OTHER

functional magnetic resonance imaging fMRI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

functional magnetic resonance imaging fMRI

functional magnetic resonance imaging fMRI

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph C Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Irvine

Irvine, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HS#2003-3139

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Studying Motor Neuron Tests
NCT01517087 COMPLETED
Episodic Memory Integration and Interference
NCT05974371 NOT_YET_RECRUITING NA
Reliability of the Human Brain Connectome
NCT02193425 COMPLETED EARLY_PHASE1