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Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder (SAILLANCE2) (SAILLANCE2)

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ClinicalTrials.gov Identifier: NCT03519789
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
Post-traumatic stress disorder (PTSD) is characterized by hypervigilance. In particular, previous works suggest that patients tend to scan constantly the environment for possible threats. The present project aims at investigating such attentional bias in patients with PTSD using the change blindness paradigm that offers the interesting possibility of studying sensitivity to sudden changes using ecological stimuli. More precisely, the investigators will investigate whether patients are more sensitive than matched controls to sudden changes in the visual environment and whether this hypersensitivity is specific or even stronger when visual information has an emotional content. The attentional bias will be measured using motor responses (accuracy and speed to indicate the occurrence of a change by pressing a button) as well as eye movements.

Condition or disease
Post-Traumatic Stress Disorder

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder
Study Start Date : May 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Post-Traumatic Stress Disorders (PTSD)
30 patients with PTSD (diagnosis based on the standard DSM criteria)
Controls
30 healthy controls without any psychiatric or neurological diagnosis



Primary Outcome Measures :
  1. Response time before the detection of neutral and emotional stimuli. [ Time Frame: Baseline: one session ]
    The explicit response of the participants will be measured with the response time before the detection of neutral and emotional stimuli.


Secondary Outcome Measures :
  1. Number of correct detections compared with the missed detections and false alarms. [ Time Frame: Baseline: one session ]
    Performances will be measured by a sensitivity index (D prime) . This sensitivity index considers the number of correct detections compared with the missed detections and false alarms.

  2. Total duration until the participant first fixed on a ROI. [ Time Frame: Baseline: one session ]
    The implicit response will be measured by the localization and duration of fixations. All fixations outside the recording field will be excluded. The main variable will be the mean latency of the first fixation in a region of interest (ROI). This variable corresponds to the total duration until the participant first fixed on a ROI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thirty patients with PTSD and 30 participants exposed to trauma without PTSD will be asked to detect neutral or emotional changes in 96 scenes.
Criteria

Inclusion Criteria:

  • a diagnosis of PTSD based on the standard DSM-IV criteria,
  • normal or corrected vision.
  • clinically stable at the testing time

Exclusion Criteria:

  • history of neurological illness or trauma that occurred in the previous six months, - pregnant and nursing women,
  • drugs use in the last 24 hours,
  • an acute ocular disorder.
  • Participants will not be under tutorship, curatorship or deprived of liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519789


Contacts
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Contact: Pierre GRANDGENEVRE +33 3 20 44 45 84 pierre.grangenevre@chru-lille.fr
Contact: Anne-Laure DEMARTY +33 3 20 44 68 91 anne-laure.demarty@chru-lille.fr

Locations
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France
University Hospital, Lille Recruiting
Lille, France, 59037
Principal Investigator: Guillaume VAIVA         
Sub-Investigator: Pierre GRANDGENEVRE         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Guillaume VAIVA University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03519789     History of Changes
Other Study ID Numbers: 2013_19.2
2013-A01498-37 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Change blindness
Eye tracking
Implicit response

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders