Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by VA Eastern Colorado Health Care System.
Recruitment status was  Recruiting
Sponsor:
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
  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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Injuries
Post-Concussion Syndrome
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on October 28, 2014