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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01644851
Other study ID # UMKC SS11-212e
Secondary ID
Status Unknown status
Phase N/A
First received July 17, 2012
Last updated December 4, 2014
Start date July 2012
Est. completion date July 2015

Study information

Verified date December 2014
Source University of Missouri, Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this pilot study is to determine the effects of computer-based training in executive functioning compared to word games on cognitive and emotional aspects of combat-related PTSD.


Description:

Many posttraumatic stress disorder (PTSD) patients either choose not to complete or do not achieve optimal response to current first-line behavioral and pharmacologic treatments. Neurocognitive research points to the potential of novel treatments targeting dorsal prefrontal function and inhibition, attention, and working memory processes. This study investigates effects of computer-based training in executive functions compared to word games on cognitive and emotional aspects of combat-related PTSD. Paper-and-pencil questionnaires, interviews, computer-administered testing, and magnetic resonance imaging will be complete before and after the intervention. Results from this pilot study will provide information concerning feasibility and treatment potential of cognitive training for PTSD.


Recruitment information / eligibility

Status Unknown status
Enrollment 40
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn

Exclusion Criteria:

- enrolled in other active treatment protocols

- current substance abuse or dependence

- current suicidal ideation

- diagnosis of a neurological disorder

- history of moderate to severe traumatic brain injury

Study Design


Intervention

Behavioral:
Executive function training
Computer-based training in executive functions, administered via www.lumosity.com website.

Locations

Country Name City State
United States Univesity of Missouri - Kansas City Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Missouri, Kansas City University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinical PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS). change from baseline to after 6 weeks of training
Primary Neural activity in prefrontal regions during cognitive and emotional processing measured by functional magnetic resonance imaging. change from baseline to after 6 weeks of training
Secondary Cognitive functioning as measured by neuropsychological assessment. change from baseline to after 6 weeks of training
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