- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01334528
Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI) (ANAM)
January 13, 2016 updated by: Lisa Brenner, VA Eastern Colorado Health Care System
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- Eastern Colorado Health Sciences Denver VA MIRECC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Automated Neuropsychological Assessment Metrics (v4; ANAM4™)
Time Frame: Over the course of 4 days
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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.
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Over the course of 4 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa A Brenner, Ph.D., Eastern Colorado Health Sciences Denver VA MIRECC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (ACTUAL)
January 1, 2016
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
April 11, 2011
First Submitted That Met QC Criteria
April 12, 2011
First Posted (ESTIMATE)
April 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 15, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-1483
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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