Mild Traumatic Brain InjuryNCT00580918
Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
An observational study of Mild Traumatic Brain Injury, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- functional magnetic resonance imaging fMRI
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mild Traumatic Brain Injury Normal health controls
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- functional magnetic resonance imaging fMRI
- Keywords
- Mild Traumatic Brain Injury, fMRI
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imaging fMRIOther
functional magnetic resonance imaging fMRI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mild Traumatic Brain Injury group Receives: Other: functional magnetic resonance imaging fMRI | |
| 2 | Normal healthy control group Receives: Other: functional magnetic resonance imaging fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI scans
Measured: three to four years post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startOct 2003
- Primary completionOct 2003
- Study completionOct 2003
Why it stopped: Nonapplicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph C Wu, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580918
- Sponsor's protocol ID
- HS#2003-3139
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2007
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
- ClinicalTrials.gov ID
- NCT00580918
- Acronym / sponsor ID
- HS#2003-3139
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury, fMRI
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Nonapplicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: functional magnetic resonance imaging fMRIMild Traumatic Brain Injury group |
| 2 | – | Other: functional magnetic resonance imaging fMRINormal healthy control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mild Traumatic Brain Injury Normal health controls
Key inclusion criteria (4 listed)
- Mild to moderate brain injury patients referred to the UCI Brain Imaging Center.
- Normal healthy control subjects (20)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional magnetic resonance imaging fMRIfunctional magnetic resonance imaging fMRI | Other | 1, 2 |
Primary outcome
fMRI scans
Time frame: three to four years post injury
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Related trials for Mild Traumatic Brain Injury
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Not yet recruiting
The PIONEER Comparative Effectiveness Study - Project 2
Head Injury Trauma, Traumatic Brain Injury, Mild
Recruiting
Neuromodulation and Neurorehabilitation for mTBI
Mild Traumatic Brain Injury, Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph C Wu, M.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI scans (time frame: three to four years post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.