Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia

Schizophrenia Clinical Trial

— SAILLANCE1  

Official title:

Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874482
• Other study ID #: 2013_19.1
• Secondary ID: 2013-A01497-38
• Status: Completed
• Start date: July 2014
• Est. completion date: November 17, 2019

Study information

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

Clinical Trial Summary

Background:

Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).

The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.

Main aim:

The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.

Secondary objectives:

To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.

To separate an explicit response (motors responses) with an implicit response (eye tracking measures).

Methodology:

30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.

Description:

This study will include one visit:

• Written consent will be obtained from all participants

• Inclusion and exclusion criteria will be checked

• An ophthalmologic test, a pregnancy test, a alcohol test and a salivary test will be realized

• Various symptoms will be assessed with the PANSS (Positive And Negative Syndrome Scale for schizophrenia) and the UPDRS (Unified Parkinson Disease Rating Scale for patients, the MOCA (Montreal Cognitive Assessment), The HAD (Hospital Anxiety and Depression Scale) and the MINI (Mini International Neuropsychiatric Interview) for all participants.

• The task will be divided in two parts:

A visuo-spatial task allowing to record saccadic eye movements (approximately 10 min).

The change blindness session lasted approximately 20 min.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 17, 2019
• Est. primary completion date: November 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal or corrected vision

• Affiliate to a social security system

• For group of patients with schizophrenia : diagnosis of schizophrenia based on the standard DSM-IV criteria and patients will be clinically stable at the testing time

Exclusion Criteria:

• History of neurological illness

• Pregnant and nursing women

• Drugs use in the last 24 hours

• Acute ocular disorder

• Under tutorship, curatorship or deprived of liberty

• For controls group : be free DSM-IV axis-I diagnoses according the MINI test.

Related Conditions & MeSH terms

• Schizophrenia

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	The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.	42 months
Secondary	sensitivity index	Performances will be measure by a sensitivity index (D prime) which considers the number of correct detections compared with the missed detections and false alarms; thus it evaluates the capacity to discriminate the signal against a background noise.	42 months
Secondary	implicit response	The implicit response will be measure by the localization and duration of fixations	42 months
Secondary	emotional response	The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli	42 months