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

Post-Traumatic Stress Disorder Clinical Trial

— SAILLANCE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519789
• Other study ID #: 2013_19.2
• Secondary ID: 2013-A01498-37
• Status: Completed
• Start date: May 2014
• Est. completion date: May 5, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
France	University Hospital, Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response time before the detection of neutral and emotional stimuli.	The explicit response of the participants will be measured with the response time before the detection of neutral and emotional stimuli.	Baseline: one session
Secondary	Number of correct detections compared with the missed detections and false alarms.	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.	Baseline: one session
Secondary	Total duration until the participant first fixed on a ROI.	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.	Baseline: one session