Clinical trial NCT01334528: Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)
Official title: Consistency of ANAM Performance in Those With Deployment Acquired Mild TBI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Post-Concussive Symptoms
Keywords: Deployment Acquired Mild Traumatic Brain Injury
Persistent Post-Concussive Symptoms
Repeated measures
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2011-04-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Automated Neuropsychological Assessment Metrics (v4; ANAM4™)
timeFrame: Over the course of 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Eastern Colorado Health Sciences Denver VA MIRECC
state: Colorado
Study officials:
affiliation: Eastern Colorado Health Sciences Denver VA MIRECC
name: Lisa A Brenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: