Mild Traumatic Brain InjuryANAMNCT01334528
Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)
An observational study of Mild Traumatic Brain Injury and Post-Concussive Symptoms, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The purpose of this project is to explore the degree to which performance consistency on neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury, Post-Concussive Symptoms
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to 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: Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.
Who may be able to join
- Between the ages of 18-45 years old
- At least one OEF/OIF deployment
- Currently receiving physical and/or mental health care through the VA Eastern Colorado Health Care System
- For TBI group - veteran must have a history of at least one deployment- related mild TBI with persistent symptoms
Who cannot join
- Effortful performance on the Test of Memory Malingering (TOMM)
- History of other significant neurological disease (other than mild TBI for the appropriate group) as assessed by interview and chart review
- History or diagnosis of deployment-related moderate or severe TBI or mild TBI without persistent symptoms for the TBI groups, or any history of deployment-related TBI for the non-TBI group, as assessed by interview and chart review
- History or diagnosis of non-deployment-related TBI
- Diagnosis of Schizophrenia or Bipolar Mood DisorderI Disorder as assessed by interview and/or chart review.
- Problematic drinking behavior that consistently exceeds recommended drinking limits per day, e.g., Diagnosis of Alcohol Abuse Disorder or Alcohol Dependence Disorder per the MINI; or five or more alcoholic drinks per day, four out of seven days per week for the previous two weeks or during the assessment process
- Use of illicit substance(s) more than five times in the two weeks before enrollment or during the testing process.
- Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Colorado Health Sciences Denver VA MIRECC
Denver, Colorado, 80220
About this study
Official title: Consistency of ANAM Performance in Those With Deployment Acquired Mild TBI
The purpose of this project is to explore the degree to which performance consistency on neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.
Read the detailed description
Mild TBI outcome studies are traditionally limited to single administration or baseline/post-injury assessment models and they often fail to show enduring deficits among persons complaining of such problems. It may be the case that our standard approach to deficit measurement in mTBI has confounded our ability to elicit the actual impairment. The proposed study could generate an assessment paradigm shift (performance over time) and afford professionals the direction to better assess and ultimately serve persons with mTBI. Additionally, research on the impact of PTSD symptoms on throughput and cognitive performance has been mixed (Bremner et al., 1995; Brenner et al, 2010; Vasterling et al., 1998, 2002, 2006) and the proposed study will yield additional data in that area.
- Keywords
- Deployment Acquired Mild Traumatic Brain Injury, Persistent Post-Concussive Symptoms, Repeated measures
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
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 |
|---|---|---|
| OEF/OIF Veterans mTBI | Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated Neuropsychological Assessment Metrics (v4; ANAM4™)
The ANAM4™ Traumatic Brain Injury (TBI) Battery is a selection of tests from the ANAM4™ library (C-SHOP, 2007) believed to be especially sensitive to mild TBI. This battery was designed to aid in the assessment of general cognitive function following a suspected brain injury or other cognitive insult. The ANAM4 TBI battery includes the following tests: Simple Reaction Time, Procedural Reaction Time, Matching to Sample, Code Substitution-Learning, Code Substitution-Delayed Memory and Mathematical Processing and takes approximately 20 minutes to complete.
Measured: Over the course of 4 days
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 startFeb 2011
- 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 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Lisa A Brenner, Ph.D., Principal investigator, Eastern Colorado Health Sciences Denver VA MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334528
- Sponsor's protocol ID
- 10-1483
- Acronym
- ANAM
- Status last verified
- Jan 2016
- First submitted
- 11 Apr 2011
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency of ANAM Performance in Those With Deployment Acquired Mild TBI
- ClinicalTrials.gov ID
- NCT01334528
- Acronym / sponsor ID
- ANAM / 10-1483
- Keywords
- Deployment Acquired Mild Traumatic Brain Injury, Persistent Post-Concussive Symptoms, Repeated measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Feb 2011
- 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.
The purpose of this project is to explore the degree to which performance consistency on neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.
Detailed description
Mild TBI outcome studies are traditionally limited to single administration or baseline/post-injury assessment models and they often fail to show enduring deficits among persons complaining of such problems. It may be the case that our standard approach to deficit measurement in mTBI has confounded our ability to elicit the actual impairment. The proposed study could generate an assessment paradigm shift (performance over time) and afford professionals the direction to better assess and ultimately serve persons with mTBI. Additionally, research on the impact of PTSD symptoms on throughput and cognitive performance has been mixed (Bremner et al., 1995; Brenner et al, 2010; Vasterling et al., 1998, 2002, 2006) and the proposed study will yield additional data in that area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OEF/OIF Veterans mTBI | – | –Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.
Key inclusion criteria (4 listed)
- Between the ages of 18-45 years old
- At least one OEF/OIF deployment
- Currently receiving physical and/or mental health care through the VA Eastern Colorado Health Care System
- For TBI group - veteran must have a history of at least one deployment- related mild TBI with persistent symptoms
Key exclusion criteria (8 listed)
- Effortful performance on the Test of Memory Malingering (TOMM)
- History of other significant neurological disease (other than mild TBI for the appropriate group) as assessed by interview and chart review
- History or diagnosis of deployment-related moderate or severe TBI or mild TBI without persistent symptoms for the TBI groups, or any history of deployment-related TBI for the non-TBI group, as assessed by interview and chart review
- History or diagnosis of non-deployment-related TBI
- Diagnosis of Schizophrenia or Bipolar Mood DisorderI Disorder as assessed by interview and/or chart review.
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
Automated Neuropsychological Assessment Metrics (v4; ANAM4™)
Time frame: Over the course of 4 days
The ANAM4™ Traumatic Brain Injury (TBI) Battery is a selection of tests from the ANAM4™ library (C-SHOP, 2007) believed to be especially sensitive to mild TBI. This battery was designed to aid in the assessment of general cognitive function following a suspected brain injury or other cognitive insult. The ANAM4 TBI battery includes the following tests: Simple Reaction Time, Procedural Reaction Time, Matching to Sample, Code Substitution-Learning, Code Substitution-Delayed Memory and Mathematical Processing and takes approximately 20 minutes to complete.
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 15 Jan 2016.
- MIRECC of the VA Rocky Mountain Network (VSN 19)Link provided by the sponsor.
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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
Eastern Colorado Health Sciences Denver VA MIRECC
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 and Post-Concussive Symptoms, 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 4 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 15 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?
Automated Neuropsychological Assessment Metrics (v4; ANAM4™) (time frame: Over the course of 4 days). 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 15 Jan 2016.