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

October 6, 2017 updated by: Central Hospital, Nancy, France

Top Down Visual Information Processing in Schizophrenia Patients With Visual Hallucinations

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VH
schizophrenia patients with visual hallucinations
Other: behavioral task : emotional priming
emotional priming task on ambiguous visual stimuli
Active Comparator: AH/NH
schizophrenia patients with auditory hallucinations or no hallucinations
Other: behavioral task : emotional priming
emotional priming task on ambiguous visual stimuli
Active Comparator: C
healthy controls
Other: behavioral task : emotional priming
emotional priming task on ambiguous visual stimuli

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of false visual perception on the emotional priming task
Time Frame: through study completion an average of 6 months
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)
through study completion an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of false visual perception on the emotional priming task depending of the emotional valence manipulated
Time Frame: through study completion an average of 6 months
The investigators will investigate if the manipulated valence of the emotional priming task influences the number of false visual perceptions of ambiguous stimuli
through study completion an average of 6 months
Cognitive performances at the neuropsychological assessment
Time Frame: through study completion an average of 6 months
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).
through study completion an average of 6 months
Psychosensory hallucinations scale scores
Time Frame: through study completion an average of 6 months
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.
through study completion an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincent LAPREVOTE, Central hospital Nancy, Centre Psychothérapique de Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID-RCB/2017-A01058-45

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on behavioral task : emotional priming

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings