Traumatic Brain Injury (TBI)NCT01118195
Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans
An observational study of Traumatic Brain Injury (TBI) and Suicidal Behavior, run by VA Eastern Colorado Health Care System.
Trial summary
This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Traumatic Brain Injury (TBI), Suicidal Behavior
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Apr 2011
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient veterans with a history of traumatic brain injury
Who may be able to join
- Diagnosis of traumatic brain injury, history of suicidal behavior.
- Age 18-74.
- Currently receiving care through the Eastern Colorado Health Care System (ECHCS) Denver VA TBI Interdisciplinary Team.
Who cannot join
- History of other significant neurological disease.
- Diagnosis of Schizophrenia.
- Test of Memory Malingering (TOMM) performance lower than 50%.
- Behavior which could be described as Substance Abuse in the 7 days prior to participation.
- Current guardianship or mention of recommendation for guardianship in medical chart within the past six months.
- Inability to read the informed consent document.
- Inability to adequately respond to questions regarding the informed consent procedure.
- Significant hearing impairment.
About this study
This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population.
- Conditions
- Traumatic Brain Injury (TBI), Suicidal Behavior
- 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 and Suicidal Behavior | Not described | |
| TBI and No Suicidal Behavior | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJan 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Cross-sectional
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118195
- Sponsor's protocol ID
- VA 05-1100
- Status last verified
- Apr 2011
- First submitted
- 4 May 2010
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans
- ClinicalTrials.gov ID
- NCT01118195
- Acronym / sponsor ID
- VA 05-1100
- Conditions
- Traumatic Brain Injury (TBI), Suicidal Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Jan 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 May 2010 (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 is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI and Suicidal Behavior | – | – |
| TBI and No Suicidal Behavior | – | – |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient veterans with a history of traumatic brain injury
Key inclusion criteria (3 listed)
- Diagnosis of traumatic brain injury, history of suicidal behavior.
- Age 18-74.
- Currently receiving care through the Eastern Colorado Health Care System (ECHCS) Denver VA TBI Interdisciplinary Team.
Key exclusion criteria (8 listed)
- History of other significant neurological disease.
- Diagnosis of Schizophrenia.
- Test of Memory Malingering (TOMM) performance lower than 50%.
- Behavior which could be described as Substance Abuse in the 7 days prior to participation.
- Current guardianship or mention of recommendation for guardianship in medical chart within the past six months.
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
Not reported in the source record.
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 26 Apr 2011.
Related trials for Traumatic Brain Injury (TBI)
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI) and Suicidal Behavior, run by VA Eastern Colorado Health Care System.
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 8 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 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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 26 Apr 2011.