Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)
This study is currently recruiting participants.
Verified July 2012 by VA Eastern Colorado Health Care System
Sponsor:
VA Eastern Colorado Health Care System
Information provided by (Responsible Party):
Lisa Brenner, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01334528
First received: April 11, 2011
Last updated: July 13, 2012
Last verified: July 2012
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Purpose
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.
| Condition |
|---|
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Mild Traumatic Brain Injury Post-Concussive Symptoms |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Consistency of ANAM Performance in Those With Deployment Acquired Mild TBI |
Resource links provided by NLM:
Further study details as provided by VA Eastern Colorado Health Care System:
Primary Outcome Measures:
- Automated Neuropsychological Assessment Metrics (v4; ANAM4™) [ Time Frame: Over the course of 4 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 75 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334528
Contacts
| Contact: Lisa A Brenner, Ph.D. | 303-399-8020 ext 2571 | Lisa.Brenner@va.gov |
| Contact: Gina M Signoracci, Ph.D. | 303-399-8020 ext 4653 | Gina.Signoracci@va.gov |
Locations
| United States, Colorado | |
| Eastern Colorado Health Sciences Denver VA MIRECC | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Principal Investigator: Lisa A Brenner, Ph.D. | |
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
| Principal Investigator: | Lisa A Brenner, Ph.D. | Eastern Colorado Health Sciences Denver VA MIRECC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lisa Brenner, Director, VISN19 MIRECC, VA Eastern Colorado Health Care System |
| ClinicalTrials.gov Identifier: | NCT01334528 History of Changes |
| Other Study ID Numbers: | 10-1483 |
| Study First Received: | April 11, 2011 |
| Last Updated: | July 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by VA Eastern Colorado Health Care System:
|
Deployment Acquired Mild Traumatic Brain Injury Persistent Post-Concussive Symptoms Repeated measures |
Additional relevant MeSH terms:
|
Brain Concussion Brain Injuries Post-Concussion Syndrome Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Head Injuries, Closed Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on May 23, 2013