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

NCT01334528 | Completed DMC

• 1 other identifier: 10-1483
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury; Post-Concussive Symptoms

Keywords

Deployment Acquired Mild Traumatic Brain Injury; Persistent Post-Concussive Symptoms; Repeated measures

Outcome Measures

Primary Outcomes (1)

• 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.

  Over the course of 4 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Study Sites (1)

Eastern Colorado Health Sciences Denver VA MIRECC

Denver, Colorado, 80220, United States

Location

Related Links

• MIRECC of the VA Rocky Mountain Network (VSN 19)

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Lisa A Brenner, Ph.D.

  Eastern Colorado Health Sciences Denver VA MIRECC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, VISN19 MIRECC

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (1)