Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01072006
First received: February 18, 2010
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This research investigates processes involved with one being able to focus on relevant information and ignore non-relevant information in veterans with PTSD and those with a history of traumatic brain injury. In addition, this study evaluates whether there is an additive effect of having both PTSD and history of TBI on ability to focus attention and inhibit distracting information.


Condition
PTSD
TBI (Traumatic Brain Injury)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Top-Down Executive Control in TBI, PTSD and Combined TBI/PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Functional magnetic resonance imaging (fMRI) to measure neural activity during attentional task [ Time Frame: Subjects will only be monitored at one time point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychodiagnostic testing (Beck Depression Scale- 2nd Edition, Clinician-Administered PTSD Scale, Combat Exposure Scale) [ Time Frame: Subjects will only be monitored at one time point ] [ Designated as safety issue: No ]
  • neuropsychological testing (Wechsler Adult Intelligence Scale, 3rd Edition, selected subtests; California Verbal Learning Test, 2nd Edition; Brief Visual Memory Test- Revised) [ Time Frame: Subjects will only be monitored at one time point ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
Group 2
PTSD (not TBI)
Group 3
TBI (no PTSD)
Group 4
Combined TBI history and PTSD

Detailed Description:

Traumatic brain injury (TBI) and PTSD both are characterized by deficits in attention, yet it is unclear as to whether this is related to an inability to focus on relevant information or ignore non-relevant information. History of TBI and PTSD are common to returning soldiers from OEF/OIF and thus is highly relevant to veteran health care. It is unclear how TBI and PTSD separately, and together, affect one's ability to focus attention versus inhibit distracting stimuli. This research investigates this issue by use of a working memory paradigm with functional magnetic resonance imaging (fMRI) that entails the subject being instructed to ignore some stimuli and remember other stimuli resulting in discrete biomarkers of (1) task-related enhancement of neural processes as well as (2) suppression of task-irrelevant neural processes. In this way, the specific aspect of attention in TBI and PTSD will be elucidated in addition to exploring whether PTSD and TBI have an additive, or even synergist, effect when combined.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

OEF/OIF veterans enrolled in the Northern California Health Care System

Criteria

Inclusion Criteria:

  • All subjects will be between 18 and 40 years of age.
  • In order to be included in the mTBI group, participants must have sustained between 1 and 3 mild TBIs. The criteria for TBI will be consistent with what the VA currently uses (i.e., American Congress of Rehabilitative Medicine).
  • More specifically, patients will have sustained a traumatically induced physiologic disruption of brain function as indicated by at least one of the following:

    • any period of loss of consciousness,
    • any loss of memory for events immediately before or after the accident,
    • any alteration in mental status at the time of the accident, and
    • focal neurologic deficits.
  • Additional criteria for TBI include:

    • TBI must have been sustained during OEF or OIF and
    • TBI must consist of less than 30 minutes loss of consciousness, posttraumatic amnesia of less than 1 hour, and no positive CT/MRI findings.
  • For PTSD group inclusion, psychiatric diagnoses will be established via the PTSD Clinical Checklist- Military (PCL-M) and the Clinician Administered PTSD Scale (CAPS).
  • For PTSD/mTBI group inclusion, the above criteria must be met for both PTSD and mTBI.
  • Control subjects will be OEF/OIF veterans with a history of exposure to combat without current or previous diagnosis of PTSD and no history of TBI.

Exclusion Criteria:

  • Subjects who meet diagnostic criteria for drug abuse/dependence over the past year will be excluded.
  • Individuals will be excluded if they have neurological confounds (e.g., baseline history of a CNS opportunistic infection, CNS neoplasm, neurosyphilis, current seizure disorder, demyelinating diseases), learning disorder, or current psychiatric disorders involving psychosis (schizophrenia, bipolar disorder with psychosis).
  • Patients will also be excluded from the study if they are claustrophobic or are taking cardiovascular medications as these are contraindications for fMRI.
  • All 4 subject groups will be matched for age and education.
  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: NCT01072006

Contacts
Contact: Michael A Cole, PhD (925) 372-2000 ext 5142 michael.cole5@va.gov

Locations
United States, California
VA Northern California HCS Recruiting
Martinez, California, United States, 94553
Contact: Michael A Cole, PhD    925-372-2000 ext 5142    michael.cole5@va.gov   
Principal Investigator: Michael A. Cole, PhD         
Sponsors and Collaborators
University of California, Berkeley
Investigators
Principal Investigator: Michael A. Cole, PhD VA Northern California HCS
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01072006     History of Changes
Other Study ID Numbers: D7031-W
Study First Received: February 18, 2010
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
TBI (Traumatic Brain Injury)
PTSD
fMRI
attention

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014