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

Mild Traumatic Brain Injury Clinical Trial

— ANAM  

Official title:

Consistency of ANAM Performance in Those With Deployment Acquired Mild TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334528
• Other study ID #: 10-1483
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: January 13, 2016
• Start date: February 2011
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Post-Concussive Symptoms

Locations

Country	Name	City	State
United States	Eastern Colorado Health Sciences Denver VA MIRECC	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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