Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia (SAILLANCE1)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • University Hospital, Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 patients with schizophrenia and 30 healthy controls

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with schizophrenia; 30 patients with schizophrenia (diagnosis based on the standard DSM criteria)
Controls; 30 healthy controls without any psychiatric or neurological diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response time	The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.	42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
implicit response	The implicit response will be measure by the localization and duration of fixations	42 months
emotional response	The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli	42 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Guillaume VAIVA, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): November 17, 2019
• Study Completion (Actual): November 17, 2019

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Change blindness; Eye tracking; Implicit response
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 2013_19.1; 2013-A01497-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No