Post-Traumatic Stress DisordersMETRAPINCT00288314
fMRI in Posttraumatic Stress Disorder (PTSD) During Working Memory Updating
An observational study of Post-Traumatic Stress Disorders and Anxiety, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorders, Anxiety, Amnesia, Dissociative
- What is being tested?
- Magnetic Resonance Imaging, Functional
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: PTSD related to sexual abuse vs controls, in right-handed females.
Who may be able to join
- Right-handed women
- Victim of sexual abuse
- Suffering from PTSD
Who cannot join
- Epilepsy
- Claustrophobia
- MRI contre-indication
- Addictive disorders
- Sightless
- Detection of a brain injury at the MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Working Memory Updating in Posttraumatic Stress Disorder (PTSD): Study of Neural Correlates Using fMRI
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.
Read the detailed 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.
- Being tested
- Magnetic Resonance Imaging, Functional
- Keywords
- PTSD, MRI, Functional, Anxiety, Working Memory, Processing speed
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Amnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging, FunctionalProcedure or surgery
Structural and functional MRI
| Study group | Role | What they receive |
|---|---|---|
| PTSD | Not described Receives: Procedure: Magnetic Resonance Imaging, Functional | |
| CONTROLS | Not described Receives: Procedure: Magnetic Resonance Imaging, Functional |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Wissam EL HAGE, MD, PhD, Principal investigator, UNIVERSITY HOSPITAL OF TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288314
- Sponsor's protocol ID
- PHRR04-WEH/METRAPI
- Acronym
- METRAPI
- Status last verified
- Mar 2010
- First submitted
- 3 Feb 2006
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Hage W, Gaillard P, Isingrini M, Belzung C. Trauma-related deficits in working memory. Cogn Neuropsychiatry. 2006 Jan;11(1):33-46. doi: 10.1080/13546800444000164.
PubMed 16537232
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Updating in Posttraumatic Stress Disorder (PTSD): Study of Neural Correlates Using fMRI
- ClinicalTrials.gov ID
- NCT00288314
- Acronym / sponsor ID
- METRAPI / PHRR04-WEH/METRAPI
- Keywords
- PTSD, MRI, Functional, Anxiety, Working Memory, Processing speed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD | – | Procedure: Magnetic Resonance Imaging, Functional |
| CONTROLS | – | Procedure: Magnetic Resonance Imaging, Functional |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- PTSD related to sexual abuse vs controls, in right-handed females.
Key inclusion criteria (3 listed)
- Right-handed women
- Victim of sexual abuse
- Suffering from PTSD
Key exclusion criteria (6 listed)
- Epilepsy
- Claustrophobia
- MRI contre-indication
- Addictive disorders
- Sightless
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging, FunctionalStructural and functional MRI | Procedure or surgery | CONTROLS, PTSD |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2010.
- Background: PubMed 16537232El-Hage W, Gaillard P, Isingrini M, Belzung C. Trauma-related deficits in working memory. Cogn Neuropsychiatry. 2006 Jan;11(1):33-46. doi: 10.1080/13546800444000164.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissam EL HAGE, MD, PhD principal investigator
UNIVERSITY HOSPITAL OF TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorders and Anxiety, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2010.