N/A
N=30
Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined
PTSD · TBI (Traumatic Brain Injury)
Bottom Line
View on ClinicalTrials.gov: NCT01072006 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Functional Magnetic Resonance Imaging (fMRI) Correlation — .21; .19; .36 r-value
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Correlation |
.21; .19; .36 | — |
| SECONDARY Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms |
27.2; 56.6; 60.4 | — |
| SECONDARY Neuropsychological Testing (Wechsler Test of Adult Reading) |
103.3; 95.2; 102.1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01072006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.