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

Completed

Conditions studied: PTSD, TBI (Traumatic Brain Injury)

In brief

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.

Key facts

Study ID

NCT01072006

Run by

VA Office of Research and Development

People needed

30

Starts

2011-06-07

Expected to finish

2017-04-21

Last updated by the study team

2017-09-12

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

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.
• 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.

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.

Where it is running

• Martinez Outpatient Clinic and Community Living Center, Martinez, CA — Martinez, California, United States

Full record on ClinicalTrials.gov

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