Traumatic Brain InjuryNCT01803048
Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI
An observational study of Traumatic Brain Injury, run by University of Arizona at 1 site in United States.
Trial summary
Abnormalities in structural and functional connectivity between brain regions have been suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant contributors to neuropsychological functioning and injury outcome. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2019
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: One hundred eighty participants aged 20-45, including 150 adults with documented mild TBI and 30 healthy controls (HC) will participate in this study. Participants in the TBI group will include 30 individuals who will be tested at two weeks post-TBI; 30 individuals who will be tested at one month post-TBI; 30 individuals who will be tested at three months post-TBI; 30 individuals who will be tested at six months post-TBI; and 30 individuals who will be tested at 12 months post-TBI. Participants will be recruited from the local area of Boston, MA, via IRB-approved flyers and advertisements placed in newspapers, on the radio and within vehicles of the local public transport system (e.g. buses and subway cars).
Who may be able to join
- English as first language
- Ability to provide informed consent
- For TBI group: documented TBI experienced within 12 months prior to testing.
Who cannot join
- Metal within the body, claustrophobia or other contraindications for MRI
- Complicating medical conditions that may influence the outcome of neuropsychological assessment or neuroimaging (e.g., HIV, brain tumor, etc.)
- Less than 9th grade education
- History of alcoholism or substance use disorder
- Excess current alcohol use or illicit substance use
- for Healthy Controls (HC): life-time history of TBI or Axis I disorder
Show all 9Show fewer
- Pregnancy (ruled out by urine β-HCG)
- Colorblindness
- for HC: Having participated in a sport with a high risk of concussive/subconcussive blows for a period of at least 1 month including but not limited to: football, rugby, boxing, ice hockey, wrestling, soccer, martial arts
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Psychiatry Department
Tucson, Arizona, 85724
About this study
Official title: A Model for Predicting Cognitive and Emotional Health From Structural and Functional Neurocircuitry Following Traumatic Brain Injury
Abnormalities in structural and functional connectivity between brain regions have been suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant contributors to neuropsychological functioning and injury outcome. The purpose of this study is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted imaging (DWI) and resting state functional MRI to compare structural and functional connectivity between individuals with documented mild TBI and healthy controls. To evaluate the significance of structural and functional connectivity for behavior, the brain imaging data will then be related to measures of cognition and emotion. Over a 4-year period, 150 adults with documented mild TBI and 30 healthy controls will participate in the study.
The study will investigate the following questions and hypotheses:
- Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter integrity across multiple stages of recovery following mild TBI relative to healthy controls. It is hypothesized that mild TBI will be associated with greater white matter abnormalities than healthy controls.
- It is hypothesized that there will be a relationship between FA, cognition and emotion as a function of the injury.
- It is hypothesized that functional connectivity will be related to FA.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Diffusion Weighted Imaging, Resting State Functional Connectivity, Cognition
- Medical subject headings
- Brain Injuries, Traumatic
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 |
|---|---|---|
| TBI | 30 individuals who will be tested at two weeks post-TBI; 30 individuals who will be tested at one month post-TBI; 30 individuals who will be tested at three months post-TBI; 30 individuals who will be tested at six months post-TBI; 30 individuals who will be tested at 12 months post-TBI. | |
| Healthy Control | 30 healthy individuals with no history of TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion Weighted Imaging Metric: fractional anisotropy (FA)
Measured: Measured on the day of the MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2019
- Study completionDec 2019
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 University of ArizonaThe 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, William D. Killgore, University of Arizona
- Investigators
- William D Killgore, Ph.D., Principal investigator, University of Arizona Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803048
- Sponsor's protocol ID
- 1407388572
- Status last verified
- Nov 2020
- First submitted
- 27 Feb 2013
- Last updated
- 4 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model for Predicting Cognitive and Emotional Health From Structural and Functional Neurocircuitry Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01803048
- Acronym / sponsor ID
- 1407388572
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Diffusion Weighted Imaging, Resting State Functional Connectivity, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Mar 2013 (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.
Abnormalities in structural and functional connectivity between brain regions have been suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant contributors to neuropsychological functioning and injury outcome. The purpose of this study is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted imaging (DWI) and resting state functional MRI to compare structural and functional connectivity between individuals with documented mild TBI and healthy controls. To evaluate the significance of structural and functional connectivity for behavior, the brain imaging data will then be related to measures of cognition and emotion. Over a 4-year period, 150 adults with documented mild TBI and 30 healthy controls will participate in the study.
The study will investigate the following questions and hypotheses:
- Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter integrity across multiple stages of recovery following mild TBI relative to healthy controls. It is hypothesized that mild TBI will be associated with greater white matter abnormalities than healthy controls.
- It is hypothesized that there will be a relationship between FA, cognition and emotion as a function of the injury.
- It is hypothesized that functional connectivity will be related to FA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI | – | –30 individuals who will be tested at two weeks post-TBI; 30 individuals who will be tested at one month post-TBI; 30 individuals who will be tested at three months post-TBI; 30 individuals who will be tested at six months post-TBI; 30 individuals who will be tested at 12 months post-TBI. |
| Healthy Control | – | –30 healthy individuals with no history of TBI |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- One hundred eighty participants aged 20-45, including 150 adults with documented mild TBI and 30 healthy controls (HC) will participate in this study. Participants in the TBI group will include 30 individuals who will be tested at two weeks post-TBI; 30 individuals who will be tested at one month post-TBI; 30 individuals who will be tested at three months post-TBI; 30 individuals who will be tested at six months post-TBI; and 30 individuals who will be tested at 12 months post-TBI. Participants will be recruited from the local area of Boston, MA, via IRB-approved flyers and advertisements placed in newspapers, on the radio and within vehicles of the local public transport system (e.g. buses and subway cars).
Key inclusion criteria (3 listed)
- English as first language
- Ability to provide informed consent
- For TBI group: documented TBI experienced within 12 months prior to testing.
Key exclusion criteria (9 listed)
- Metal within the body, claustrophobia or other contraindications for MRI
- Complicating medical conditions that may influence the outcome of neuropsychological assessment or neuroimaging (e.g., HIV, brain tumor, etc.)
- Less than 9th grade education
- History of alcoholism or substance use disorder
- Excess current alcohol use or illicit substance use
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
Diffusion Weighted Imaging Metric: fractional anisotropy (FA)
Time frame: Measured on the day of the MRI scan
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 4 Nov 2020.
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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.
William D Killgore, Ph.D. principal investigator
University of Arizona Psychiatry Department
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, run by University of Arizona 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 3 inclusion and 9 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 4 Nov 2020. 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?
Diffusion Weighted Imaging Metric: fractional anisotropy (FA) (time frame: Measured on the day of the MRI scan). 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 4 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.