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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072006
First Posted: February 19, 2010
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
VA Office of Research and Development
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • Functional Magnetic Resonance Imaging (fMRI) Correlation [ Time Frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported. ]
    Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.


Secondary Outcome Measures:
  • Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms [ Time Frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported. ]
    The PCL is a 17-item questionnaire that measures PTSD symptoms on a scale that ranges from 17-85 points. The total severity score is reported below. A higher score means a higher level of PTSD symptoms.

  • Neuropsychological Testing (Wechsler Test of Adult Reading) [ Time Frame: These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported. ]
    This test provides an estimate of pre-morbid IQ, which is important to report so that the patient sample can be compared to other similar studies for comparable IQ level and so that pre-morbid IQ can be considered as a potential variable. There are 50 items that are each given a score of 1, so the range of scores is 0-50. The raw score is then converted into an estimated IQ score based on age and education. The scores reported below reflect this estimated IQ score, where normal IQ scores range from 75 as low average to 125 as high average.


Enrollment: 30
Actual Study Start Date: June 7, 2011
Study Completion Date: April 21, 2017
Primary Completion Date: December 1, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Group
Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
PTSD Group
PTSD (not TBI)
TBI Group
TBI (no PTSD)
TBI+PTSD Group
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01072006


Locations
United States, California
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
Martinez, California, United States, 94553
Sponsors and Collaborators
VA Office of Research and Development
University of California, Berkeley
Investigators
Principal Investigator: Juliana V. Baldo, PhD Martinez Outpatient Clinic and Community Living Center, Martinez, CA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01072006     History of Changes
Other Study ID Numbers: D7031-W
First Submitted: February 18, 2010
First Posted: February 19, 2010
Results First Submitted: January 3, 2017
Results First Posted: April 24, 2017
Last Update Posted: September 12, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
TBI (Traumatic Brain Injury)
PTSD
fMRI
attention

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