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

PTSD Clinical Trial

Official title:

Top-Down Executive Control in TBI, PTSD and Combined TBI/PTSD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01072006
• Other study ID #: D7031-W
• Status: Active, not recruiting
• Phase: N/A
• First received: February 18, 2010
• Last updated: April 28, 2016
• Start date: June 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• PTSD
• TBI (Traumatic Brain Injury)

Locations

Country	Name	City	State
United States	Martinez Outpatient Clinic and Community Living Center, Martinez, CA	Martinez	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of California, Berkeley

Country where clinical trial is conducted

United States, 

References & 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):347-52. doi: 10.1037/neu0000043. Epub 2013 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging (fMRI) to measure neural activity during attentional task		Subjects will only be monitored at one time point	No
Secondary	psychodiagnostic testing (Beck Depression Scale- 2nd Edition, Clinician-Administered PTSD Scale, Combat Exposure Scale)		Subjects will only be monitored at one time point	No
Secondary	neuropsychological testing (Wechsler Adult Intelligence Scale, 3rd Edition, selected subtests; California Verbal Learning Test, 2nd Edition; Brief Visual Memory Test- Revised)		Subjects will only be monitored at one time point	No