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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00288314
Other study ID # PHRR04-WEH/METRAPI
Secondary ID
Status Completed
Phase N/A
First received February 3, 2006
Last updated March 16, 2010
Start date January 2007
Est. completion date May 2008

Study information

Verified date March 2010
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life Sciences
Study type Observational

Clinical Trial Summary

Neuropsychological studies investigating trauma-exposed and posttraumatic stress disorder (PTSD) subjects have generally underlined the significantly poorer performance of tasks that require attention, concentration, and verbal memory, and difficulty in regulating memories surrounding the traumatic event. A previous study (El Hage et al. Cognitive Neuropsychiatry, 2006) revealed that the trauma-exposed subjects scored higher on anxiety/depression scales, and lower on processing speed tests. Moreover, the study showed significant impairment in working memory partially mediated by speed processing, but not by anxiety or depression. These results suggest that processing speed makes a major contribution to trauma-related working memory decline, and needs to be investigated in further studies.The aim of the present study is to explore correlation between hippocampus volume, frontal dysfunction and cognitive slowing in trauma-exposed subjects, while examining brain activation during performance of working memory tasks using functional magnetic resonance.


Description:

Working memory performance will be assessed using the "3-back test", and processing speed evaluated with "words comparison test". The study will be conducted on 2 years. The study should include 18 right-handed females victims of sexual abuse and suffering from PTSD, and 18 controls right-handed females without any history of abuse ad not suffering from PTSD. Brain activation will be measured during performance of working memory tasks (3-back test) and processing speed test using functional magnetic resonance.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Right-handed women

- Victim of sexual abuse

- Suffering from PTSD

Exclusion Criteria:

- Epilepsy

- Claustrophobia

- MRI contre-indication

- Addictive disorders

- Sightless

- Detection of a brain injury at the MRI

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Intervention

Procedure:
Magnetic Resonance Imaging, Functional
Structural and functional MRI

Locations

Country Name City State
France University Hospital of Tours Tours Centre

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (1)

El-Hage W, Gaillard P, Isingrini M, Belzung C. Trauma-related deficits in working memory. Cogn Neuropsychiatry. 2006 Jan;11(1):33-46. — View Citation

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