Traumatic Brain InjuryNCT00478400
Awareness of Deficit After Combat-related Brain Injury
An observational study of Traumatic Brain Injury and Veterans, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will use MRI imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Brain Injury, Veterans
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2007to 31 Oct 2016
- 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 55 years
- All sexes
- Adult
Study population: Veterans will be recruited through the Middleton VA Hospital in Madison, WI. Civilian participants will be recruited from a previous study led by Dr. Johnson.
Who may be able to join
- History of traumatic brain injury at least 12 months prior to enrollment
- Control Group: No history of traumatic brain injury
Who cannot join
- Claustrophobia
- Metallic or electronic implants or devices that are not MRI-safe
- Foreign metal, such as shrapnel, in the body
Trial locations and contacts
1 site in 1 country.
United States1 site
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
About this study
This study will use MRI imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury.
Read the detailed description
The extent of recovery from brain injury is often difficult to predict because of our limited understanding of how the brain changes as it heals. New brain imaging methods may help in this regard. One imaging technique called functional magnetic resonance imaging (fMRI) has made it possible to study the brain "at work"; that is, we can see regions of the brain that are active during particular tasks such as focusing attention, making decisions, or remembering words and pictures. Another MRI method called diffusion tensor imaging provides information on the pathways between brain regions that may be altered with brain injury.
The goals of this research are to 1) determine the brain regions involved in making accurate judgments about one's abilities and disabilities after a brain injury and whether damage to these brain areas affects outcome; and 2) examine how recovery of cognitive and physical abilities relates to changes in brain function over time. In order to accomplish the first goal we will recruit Veterans who have sustained a head injury and matched control subjects. For the second goal, we are asking patients and controls who have previously participated in brain injury research with our lab to come back for another visit at three years post-injury.
- Conditions
- Traumatic Brain Injury, Veterans
- Keywords
- Recovery, Magnetic resonance imaging, Awareness, Neurologic deficits
- Medical subject headings
- Brain Injuries, Traumatic, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants who have had a TBI | (recruited by invitation only) 1. Must be between 1- and 6-years post-injury 2. Closed head injury 3. Evidence of loss of consciousness 4. Must have an informant (friend, spouse, child etc.) 5. Audit-C < 7, PCL < 65 and PHQ-9 < 15 | |
| Participants with No history of TBI | (Recruited by invitation only) 1. No history of TBI 2. Must have an informant (friend, spouse, child etc.) | |
| Veterans with History of TBI | 1. Must be between 1- and 6-years post-injury 2. Closed head injury 3. Evidence of loss of consciousness 4. Must have an informant (friend, spouse, child etc.) 5. Audit-C < 7, PCL < 65 and PHQ-9 < 15 | |
| US Veterans with No history of TBI | 1. No history of TBI 2. Must have an informant (friend, spouse, child etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition change at study endpoint between TBI and controls
Measured: Greater than 3 years post-injury
Longitudinal change in white matter
Participants will include post-TBI in survivors the investigators have studied previously
Measured: 2 months, 1 year, and greater than 3 years post-injury
Longitudinal change in whole brain morphology
Participants will include post-TBI in survivors the investigators have studied previously
Measured: 2 months, 1 year, and greater than 3 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 posted24 May 2007 (estimated)
- Study start1 Oct 2007
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Sterling C Johnson, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478400
- Sponsor's protocol ID
- NEUC-029-06S
- Other IDs
- H-2006-0256
- Status last verified
- Dec 2017
- First submitted
- 22 May 2007
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Deficit After Combat-related Brain Injury
- ClinicalTrials.gov ID
- NCT00478400
- Acronym / sponsor ID
- NEUC-029-06S
- Conditions
- Traumatic Brain Injury, Veterans
- Keywords
- Recovery, Magnetic resonance imaging, Awareness, Neurologic deficits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Wisconsin, Madison
- Study start
- 1 Oct 2007 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 24 May 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.
This study will use MRI imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury.
Detailed description
The extent of recovery from brain injury is often difficult to predict because of our limited understanding of how the brain changes as it heals. New brain imaging methods may help in this regard. One imaging technique called functional magnetic resonance imaging (fMRI) has made it possible to study the brain "at work"; that is, we can see regions of the brain that are active during particular tasks such as focusing attention, making decisions, or remembering words and pictures. Another MRI method called diffusion tensor imaging provides information on the pathways between brain regions that may be altered with brain injury.
The goals of this research are to 1) determine the brain regions involved in making accurate judgments about one's abilities and disabilities after a brain injury and whether damage to these brain areas affects outcome; and 2) examine how recovery of cognitive and physical abilities relates to changes in brain function over time. In order to accomplish the first goal we will recruit Veterans who have sustained a head injury and matched control subjects. For the second goal, we are asking patients and controls who have previously participated in brain injury research with our lab to come back for another visit at three years post-injury.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants who have had a TBI | – | –(recruited by invitation only) 1. Must be between 1- and 6-years post-injury 2. Closed head injury 3. Evidence of loss of consciousness 4. Must have an informant (friend, spouse, child etc.) 5. Audit-C < 7, PCL < 65 and PHQ-9 < 15 |
| Participants with No history of TBI | – | –(Recruited by invitation only) 1. No history of TBI 2. Must have an informant (friend, spouse, child etc.) |
| Veterans with History of TBI | – | –1. Must be between 1- and 6-years post-injury 2. Closed head injury 3. Evidence of loss of consciousness 4. Must have an informant (friend, spouse, child etc.) 5. Audit-C < 7, PCL < 65 and PHQ-9 < 15 |
| US Veterans with No history of TBI | – | –1. No history of TBI 2. Must have an informant (friend, spouse, child etc.) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Veterans will be recruited through the Middleton VA Hospital in Madison, WI. Civilian participants will be recruited from a previous study led by Dr. Johnson.
Key inclusion criteria (2 listed)
- History of traumatic brain injury at least 12 months prior to enrollment
- Control Group: No history of traumatic brain injury
Key exclusion criteria (3 listed)
- Claustrophobia
- Metallic or electronic implants or devices that are not MRI-safe
- Foreign metal, such as shrapnel, in the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognition change at study endpoint between TBI and controls
Time frame: Greater than 3 years post-injury
Longitudinal change in white matter
Time frame: 2 months, 1 year, and greater than 3 years post-injury
Participants will include post-TBI in survivors the investigators have studied previously
Longitudinal change in whole brain morphology
Time frame: 2 months, 1 year, and greater than 3 years post-injury
Participants will include post-TBI in survivors the investigators have studied previously
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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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.
Sterling C Johnson, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
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 Traumatic Brain Injury and Veterans, run by VA Office of Research and Development 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 22 Dec 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognition change at study endpoint between TBI and controls (time frame: Greater than 3 years post-injury). The study lists 3 primary outcomes in all. 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 22 Dec 2017.