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Visual Information Processing in Schizophrenia Patients With Visual Hallucinations (SHALL)

Primary Purpose

Schizophrenia, Visual Hallucination, Auditory Hallucination

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
behavioral task : emotional priming
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, Visual Hallucination, False Perception, emotional priming

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

All Groups:

  • Age between 18 and 55 years
  • Affiliation to or benefiting from a social security
  • Visual acuity normal or corrected to normal
  • Person who received and understood the complete information about the organization of the research and gave written and free informed consent before participating in the study

Group of patients with schizophrenia with visual hallucination (HV) with or without auditory hallucination (HA) (HV group):

  • Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria
  • Presence of a hallucinatory visual symptomatology (HV) in the history of the disease measured by the Psychosensory hallucination scale (PSAS).
  • The presence of a hallucinatory symptomatology in auditory mode (HA) in addition to the HV is not a criterion of non-inclusion.

Group of patients with schizophrenia either with auditory hallucination (HA) but without visual hallucination (HV) or no hallucination, auditory or visual (NH) (HA / NH group)

  • Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria
  • Presence of a hallucinatory symptomatology in auditory mode (HA) in the history of the disease measured by the PSAS or absence of any hallucinatory manifestations in the history of the disease
  • Absence of visual hallucinatory symptomatology (HV) in the history of the disease as measured by PSAS

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    VH

    AH/NH

    C

    Arm Description

    schizophrenia patients with visual hallucinations

    schizophrenia patients with auditory hallucinations or no hallucinations

    healthy controls

    Outcomes

    Primary Outcome Measures

    Number of false visual perception on the emotional priming task
    Number of false perception made by participants on an ambiguous visual stimulus i.e when a participant identifies incorrectly an ambiguous stimulus as a genuine percept (for example a participant sees a face in a noisy grey pattern)

    Secondary Outcome Measures

    number of false visual perception on the emotional priming task depending of the emotional valence manipulated
    The investigators will investigate if the manipulated valence of the emotional priming task influences the number of false visual perceptions of ambiguous stimuli
    Cognitive performances at the neuropsychological assessment
    Cognitive performances at the neuropsychological assessment conducted for both groups of schizophrenia patients. Neuropsychological assessment will provide performance scores on different cognitive functions : episodic memory (California Verbal Learning Test), visual memory (delayed match to sample task), working memory (forward and backward digit span, n-back task), sustained attention (test of attentional performance battery), divided attention (test of attentional performance battery), inhibition (test of attentional performance battery), processing speed (coding) and visual perception and processing (visual object space perception task).
    Psychosensory hallucinations scale scores
    scores on the Psychosensory hallucinations scale conducted for both schizophrenia patients groups. This scale provides a complete evaluation of hallucinations in all modalities as well as the impact of these symptoms on daily life.

    Full Information

    First Posted
    June 9, 2017
    Last Updated
    October 6, 2017
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03188133
    Brief Title
    Visual Information Processing in Schizophrenia Patients With Visual Hallucinations
    Acronym
    SHALL
    Official Title
    Top Down Visual Information Processing in Schizophrenia Patients With Visual Hallucinations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 17, 2017 (Anticipated)
    Primary Completion Date
    May 1, 2018 (Anticipated)
    Study Completion Date
    October 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Occurrence of visual hallucinations (VHs) in schizophrenia depend in part on disorders in the processing of late visual information (Top-Down). The broader question of how these top-down mechanisms (cognitive and / or emotional mechanisms) are involved in the occurrence of VHs remains to be specified and very few behavioral studies have so far been interested. The investigators propose to study the implication of Top-Down mechanisms in the visual hallucinatory manifestations, more specifically in the processing of ambiguous stimuli during an emotional priming task. Schizophrenia patients with VHs would have more false visual perceptions in the treatment of ambiguous stimuli than schizophrenia patients with auditory hallucinations or no hallucinations (AH/NH) and healthy controls.
    Detailed Description
    In schizophrenia patients with auditory hallucinations, top-down mechanism on perceptual processing could be illustrated by tasks of listening to white noise. These studies show that psychotic subjects detect more words and phrases when exposed to these stimuli. In schizophrenia patients with VHs, to our knowledge no study have explored the mechanism of false perception. Thus, we propose to experimentally manipulate the implication of Top-Down mechanisms on visual perception using an emotional priming task. This paradigm has already been used in this population to explain the mechanisms underlying productive symptoms. For example, in an emotional priming task authors have shown that a negative valence primer contributes to the implementation of an interpretive bias in a confidence judgment task. The aim of the present study is to explore the implication of these Top-Down mechanisms in hallucinatory manifestations, more specifically on the treatment of ambiguous visual stimuli during an emotional priming task by manipulating the emotional valence of the primer. The goal is to determine how emotional environmental elements contribute to the formation of erroneous perceptions in patients with schizophrenia with VHs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Visual Hallucination, Auditory Hallucination, False Perception
    Keywords
    Schizophrenia, Visual Hallucination, False Perception, emotional priming

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VH
    Arm Type
    Experimental
    Arm Description
    schizophrenia patients with visual hallucinations
    Arm Title
    AH/NH
    Arm Type
    Active Comparator
    Arm Description
    schizophrenia patients with auditory hallucinations or no hallucinations
    Arm Title
    C
    Arm Type
    Active Comparator
    Arm Description
    healthy controls
    Intervention Type
    Other
    Intervention Name(s)
    behavioral task : emotional priming
    Intervention Description
    emotional priming task on ambiguous visual stimuli
    Primary Outcome Measure Information:
    Title
    Number of false visual perception on the emotional priming task
    Description
    Number of false perception made by participants on an ambiguous visual stimulus i.e when a participant identifies incorrectly an ambiguous stimulus as a genuine percept (for example a participant sees a face in a noisy grey pattern)
    Time Frame
    through study completion an average of 6 months
    Secondary Outcome Measure Information:
    Title
    number of false visual perception on the emotional priming task depending of the emotional valence manipulated
    Description
    The investigators will investigate if the manipulated valence of the emotional priming task influences the number of false visual perceptions of ambiguous stimuli
    Time Frame
    through study completion an average of 6 months
    Title
    Cognitive performances at the neuropsychological assessment
    Description
    Cognitive performances at the neuropsychological assessment conducted for both groups of schizophrenia patients. Neuropsychological assessment will provide performance scores on different cognitive functions : episodic memory (California Verbal Learning Test), visual memory (delayed match to sample task), working memory (forward and backward digit span, n-back task), sustained attention (test of attentional performance battery), divided attention (test of attentional performance battery), inhibition (test of attentional performance battery), processing speed (coding) and visual perception and processing (visual object space perception task).
    Time Frame
    through study completion an average of 6 months
    Title
    Psychosensory hallucinations scale scores
    Description
    scores on the Psychosensory hallucinations scale conducted for both schizophrenia patients groups. This scale provides a complete evaluation of hallucinations in all modalities as well as the impact of these symptoms on daily life.
    Time Frame
    through study completion an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    All Groups: Age between 18 and 55 years Affiliation to or benefiting from a social security Visual acuity normal or corrected to normal Person who received and understood the complete information about the organization of the research and gave written and free informed consent before participating in the study Group of patients with schizophrenia with visual hallucination (HV) with or without auditory hallucination (HA) (HV group): Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria Presence of a hallucinatory visual symptomatology (HV) in the history of the disease measured by the Psychosensory hallucination scale (PSAS). The presence of a hallucinatory symptomatology in auditory mode (HA) in addition to the HV is not a criterion of non-inclusion. Group of patients with schizophrenia either with auditory hallucination (HA) but without visual hallucination (HV) or no hallucination, auditory or visual (NH) (HA / NH group) Schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria Presence of a hallucinatory symptomatology in auditory mode (HA) in the history of the disease measured by the PSAS or absence of any hallucinatory manifestations in the history of the disease Absence of visual hallucinatory symptomatology (HV) in the history of the disease as measured by PSAS
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vincent LAPREVOTE
    Phone
    0033+383926822
    Email
    vincent.laprevote@cpn-laxou.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Florent BERNARDIN
    Phone
    0033+383925034
    Email
    florent.bernardin@cpn-laxou.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent LAPREVOTE
    Organizational Affiliation
    Central hospital Nancy, Centre Psychothérapique de Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25020079
    Citation
    Catalan A, Simons CJ, Bustamante S, Drukker M, Madrazo A, de Artaza MG, Gorostiza I, van Os J, Gonzalez-Torres MA. Novel evidence that attributing affectively salient signal to random noise is associated with psychosis. PLoS One. 2014 Jul 14;9(7):e102520. doi: 10.1371/journal.pone.0102520. eCollection 2014.
    Results Reference
    background
    PubMed Identifier
    17906248
    Citation
    Hoffman RE, Woods SW, Hawkins KA, Pittman B, Tohen M, Preda A, Breier A, Glist J, Addington J, Perkins DO, McGlashan TH. Extracting spurious messages from noise and risk of schizophrenia-spectrum disorders in a prodromal population. Br J Psychiatry. 2007 Oct;191:355-6. doi: 10.1192/bjp.bp.106.031195.
    Results Reference
    background
    PubMed Identifier
    20360211
    Citation
    Galdos M, Simons C, Fernandez-Rivas A, Wichers M, Peralta C, Lataster T, Amer G, Myin-Germeys I, Allardyce J, Gonzalez-Torres MA, van Os J. Affectively salient meaning in random noise: a task sensitive to psychosis liability. Schizophr Bull. 2011 Nov;37(6):1179-86. doi: 10.1093/schbul/sbq029. Epub 2010 Apr 1.
    Results Reference
    background
    PubMed Identifier
    20919787
    Citation
    Hooker CI, Tully LM, Verosky SC, Fisher M, Holland C, Vinogradov S. Can I trust you? Negative affective priming influences social judgments in schizophrenia. J Abnorm Psychol. 2011 Feb;120(1):98-107. doi: 10.1037/a0020630.
    Results Reference
    background

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    Visual Information Processing in Schizophrenia Patients With Visual Hallucinations

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