Traumatic Brain InjuryNCT01334463
Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With TBI, PTSD, or Both
An observational study of Traumatic Brain Injury and Post Traumatic Stress Disorder, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
1. To determine whether tasks taken from the field of cognitive neuroscience can detect and distinguish impairments in executive function above and beyond standard neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI), b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD 2. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Post Traumatic Stress Disorder, Suicide
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participants in this observational study will be recruited from the following populations of OEF/OIF Veterans: 1.) those seeking mental health, rehabilitative, psychological or other services within the Veterans Health Administration (VHA) Eastern Colorado Healthcare System , 2.) those in existing clinical and research databases, and 3.) Veterans in the community not seeking care within the VHA.
Who may be able to join
- Between the ages of 18-45 years old
- At least one OEF/OIF deployment
- Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System
Who cannot join
- History of other significant neurological disease (other than mild TBI for the appropriate groups) as assessed by interview and chart review
- History or diagnosis of lifetime moderate or severe TBI for the TBI groups, or any history of TBI for the non-TBI groups, as assessed by interview and chart review
- History or diagnosis of non-active duty-related mild TBI or PTSD disorder as assessed by interview and/or chart review
- Diagnosis of schizophrenia or bipolar I disorder as assessed by interview and/or chart review
- Computerized Assessment of Response Bias (CARB) performance categorized as Very Poor or Symptom Exaggerator
- Problematic drinking behavior that consistently exceeds recommended drinking limits per day, e.g., Diagnosis of Alcohol Abuse Disorder or Alcohol Dependence Disorder per the SCID; or five or more alcoholic drinks per day, four out of seven days per week for the previous two weeks
Show all 9Show fewer
- Use of illicit substance(s) more than five times in the two weeks before enrollment
- Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure
- Contraindication to having an MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Both
- To determine whether tasks taken from the field of cognitive neuroscience can detect and distinguish impairments in executive function above and beyond standard neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI), b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD
- To determine whether performance on these tasks is linked to pertinent psychiatric outcomes (e.g. history of suicidality), which is associated with compromised executive function and impulsivity.
- To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.
Read the detailed description
Individuals who served in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) are reporting histories of traumatic brain injury (TBI) and symptoms associated with post traumatic stress disorder (PTSD). Standard neuropsychological measures are ineffective at distinguishing between TBI and PTSD. This pilot project will examine whether methods from cognitive neuroscience can determine the effects of TBI and/or PTSD on executive function. Executive function includes many aspects of goal-oriented behavior, including the ability to inhibit inappropriate behaviors and thoughts. In the proposed study, the investigators are focusing on inhibitory processing, as it is a core component of executive function. Although both TBI and PTSD compromise executive function and TBI often occurs in the context of a traumatic event, very little research has attempted to disentangle the effects that each of these conditions has on inhibitory control. In addition, the investigators are interested in how disinhibition may be linked to impulsive real-world behaviors, such as suicidal tendencies, which are observed at elevated rates in individuals with TBI as well as those with PTSD. Knowing the ways in which inhibitory functions are compromised in these individuals should aid in the development of appropriate treatments aimed at functional improvement for those with mild TBI, PTSD, or mild TBI+PTSD.
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic, Suicide, Self-Injurious Behavior
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 |
|---|---|---|
| mTBI+PTSD | History of active duty-related mild TBI and history of active duty-related PTSD | |
| mTBI Only | History of active duty-related mild TBI and no history of active duty-related PTSD | |
| PTSD Only | No history of active duty-related mild TBI and history of active duty-related PTSD | |
| No mTBI, No PTSD | No history of active duty-related mild TBI and no history of active duty-related PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa Gambling Test
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2016
- Study completionJan 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.
- 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund, University of Colorado, Boulder
- Responsible party
- Sponsor
- Investigators
- Lisa A Brenner, Ph.D., Principal investigator, VA Office of Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334463
- Sponsor's protocol ID
- 08-0502
- Status last verified
- Jan 2016
- First submitted
- 11 Apr 2011
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Dysfunction and Self-Harm Behavior: An Examination of Veterans With Traumatic Brain Injury, Post Traumatic Stress Disorder, or Both
- ClinicalTrials.gov ID
- NCT01334463
- Acronym / sponsor ID
- 08-0502
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund, University of Colorado, Boulder
- Study start
- Jul 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Apr 2011 (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.
- To determine whether tasks taken from the field of cognitive neuroscience can detect and distinguish impairments in executive function above and beyond standard neuropsychological measures in individuals with: a.) Mild Traumatic Brain Injury (TBI), b.) Post Traumatic Stress Disorder (PTSD), c.)Mild TBI+PTSD
- To determine whether performance on these tasks is linked to pertinent psychiatric outcomes (e.g. history of suicidality), which is associated with compromised executive function and impulsivity.
- To determine whether information regarding brain anatomy can provide additional information above and beyond behavior performance in distinguishing between these two groups.
Detailed description
Individuals who served in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) are reporting histories of traumatic brain injury (TBI) and symptoms associated with post traumatic stress disorder (PTSD). Standard neuropsychological measures are ineffective at distinguishing between TBI and PTSD. This pilot project will examine whether methods from cognitive neuroscience can determine the effects of TBI and/or PTSD on executive function. Executive function includes many aspects of goal-oriented behavior, including the ability to inhibit inappropriate behaviors and thoughts. In the proposed study, the investigators are focusing on inhibitory processing, as it is a core component of executive function. Although both TBI and PTSD compromise executive function and TBI often occurs in the context of a traumatic event, very little research has attempted to disentangle the effects that each of these conditions has on inhibitory control. In addition, the investigators are interested in how disinhibition may be linked to impulsive real-world behaviors, such as suicidal tendencies, which are observed at elevated rates in individuals with TBI as well as those with PTSD. Knowing the ways in which inhibitory functions are compromised in these individuals should aid in the development of appropriate treatments aimed at functional improvement for those with mild TBI, PTSD, or mild TBI+PTSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mTBI+PTSD | – | –History of active duty-related mild TBI and history of active duty-related PTSD |
| mTBI Only | – | –History of active duty-related mild TBI and no history of active duty-related PTSD |
| PTSD Only | – | –No history of active duty-related mild TBI and history of active duty-related PTSD |
| No mTBI, No PTSD | – | –No history of active duty-related mild TBI and no history of active duty-related PTSD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants in this observational study will be recruited from the following populations of OEF/OIF Veterans: 1.) those seeking mental health, rehabilitative, psychological or other services within the Veterans Health Administration (VHA) Eastern Colorado Healthcare System , 2.) those in existing clinical and research databases, and 3.) Veterans in the community not seeking care within the VHA.
Key inclusion criteria (3 listed)
- Between the ages of 18-45 years old
- At least one OEF/OIF deployment
- Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System
Key exclusion criteria (9 listed)
- History of other significant neurological disease (other than mild TBI for the appropriate groups) as assessed by interview and chart review
- History or diagnosis of lifetime moderate or severe TBI for the TBI groups, or any history of TBI for the non-TBI groups, as assessed by interview and chart review
- History or diagnosis of non-active duty-related mild TBI or PTSD disorder as assessed by interview and/or chart review
- Diagnosis of schizophrenia or bipolar I disorder as assessed by interview and/or chart review
- Computerized Assessment of Response Bias (CARB) performance categorized as Very Poor or Symptom Exaggerator
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
Iowa Gambling Test
Time frame: One time
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 25 Jan 2016.
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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.
Lisa A Brenner, Ph.D. principal investigator
VA Office of Research and Development
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 Post Traumatic Stress Disorder, run by VA Eastern Colorado Health Care System 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 25 Jan 2016. 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?
Iowa Gambling Test (time frame: One time). 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 2016.