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

NCT01072006 | Completed Results

• 1 other identifier: D7031-W
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD; TBI (Traumatic Brain Injury)

Keywords

TBI (Traumatic Brain Injury); PTSD; fMRI; attention

Outcome Measures

Primary Outcomes (1)

• Functional Magnetic Resonance Imaging (fMRI) Correlation

  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.

  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.

Secondary Outcomes (2)

• Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms

  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.

• Neuropsychological Testing (Wechsler Test of Adult Reading)

  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.

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, Berkeley: collaborator

Study Sites (1)

Martinez Outpatient Clinic and Community Living Center, Martinez, CA

Martinez, California, 94553, United States

Location

Related Publications (1)

• Sozda CN, Muir JJ, Springer US, Partovi D, Cole MA. Differential learning and memory performance in OEF/OIF veterans for verbal and visual material. Neuropsychology. 2014 May;28(3):347-352. doi: 10.1037/neu0000043. Epub 2013 Nov 18.

  PMID: 24245926 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Juliana Baldo
• Organization: VANCHCS

juliana.baldo@va.gov

925-372-4649

Study Officials

• Juliana V. Baldo, PhD

  Martinez Outpatient Clinic and Community Living Center, Martinez, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: June 7, 2011
• Primary Completion: December 1, 2015
• Study Completion: April 21, 2017
• Last Updated: September 12, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)