Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 95 of 3000 for:    Schizophrenia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874482
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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.


Condition or disease
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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia
Actual Study Start Date : July 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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



Primary Outcome Measures :
  1. response time [ Time Frame: 42 months ]
    The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.


Secondary Outcome Measures :
  1. sensitivity index [ Time Frame: 42 months ]
    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.

  2. implicit response [ Time Frame: 42 months ]
    The implicit response will be measure by the localization and duration of fixations

  3. emotional response [ Time Frame: 42 months ]
    The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 patients with schizophrenia and 30 healthy controls
Criteria

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.

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): NCT02874482


Contacts
Layout table for location contacts
Contact: Pierre GRANDGENEVRE +33 3 20 44 45 84 pierre.grandgenevre@chru-lille.fr
Contact: Anne-Laure DEMARTY +33 3 20 44 68 91 anne-laure.demarty@chru-lille.fr

Locations
Layout table for location information
France
University Hospital, Lille Recruiting
Lille, France, 59037
Principal Investigator: Guillaume VAIVA         
Sub-Investigator: Pierre GRANDGENEVRE         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Guillaume VAIVA University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02874482     History of Changes
Other Study ID Numbers: 2013_19.1
2013-A01497-38 ( Other Identifier: ANSM )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Schizophrenia
Change blindness
Eye tracking
Implicit response
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders