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

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ClinicalTrials.gov Identifier: NCT01334528
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Lisa Brenner, VA Eastern Colorado Health Care System

Brief 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.

Condition or disease
Mild Traumatic Brain Injury Post-Concussive 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 Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consistency of ANAM Performance in Those With Deployment Acquired Mild TBI
Study Start Date : February 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334528


Locations
United States, Colorado
Eastern Colorado Health Sciences Denver VA MIRECC
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
Principal Investigator: Lisa A Brenner, Ph.D. Eastern Colorado Health Sciences Denver VA MIRECC

Additional Information:
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
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Lisa Brenner, VA Eastern Colorado Health Care System:
Deployment Acquired Mild Traumatic Brain Injury
Persistent Post-Concussive Symptoms
Repeated measures

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating