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French Source-monitoring Task (SOUMO)

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ClinicalTrials.gov Identifier: NCT04237155
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief Summary:

Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.

The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Questionnaire Other: Cognitive tests Not Applicable

Detailed Description:
The study will include 2 steps: 1) validation of the verbal material necessary for the creation of the source-monitoring task and 2) testing the task.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: For step 1, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete a verbal material scoring questionnaire. For step 2, two populations of participants: 30 healthy volunteers and 30 patients with schizophrenia will have to complete the source-monitoring task which will be created from step 1 as well as the task of reference (Brunelin et al., 2008).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Healthy controls involved in step 1
30 healthy individuals will complete a verbal material scoring questionnaire
Other: Questionnaire
Subjects will complete a verbal material scoring questionnaire

Patients with schizophrenia involved in step 1
30 patients with schizophrenia will complete a verbal material scoring questionnaire
Other: Questionnaire
Subjects will complete a verbal material scoring questionnaire

Healthy controls involved in step 2
30 healthy individuals will complete the source-monitoring task which will be created from step 1 as well as the task of reference
Other: Cognitive tests
Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference

Patients with schizophrenia involved in step 2
30 patients with schizophrenia will complete the source-monitoring task which will be created from step 1 as well as the task of reference
Other: Cognitive tests
Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference




Primary Outcome Measures :
  1. Source-monitoring performances [ Time Frame: one day ]
    Performances (calculated as the number of accurate source responses and the number of errors) obtained at the new source-monitoring task and at the source-monitoring task of reference (Brunelin et al., 2006).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and Women aged between 18 and 45
  • Having given their written informed consent
  • Native French speakers
  • Normal or corrected-to-normal vision
  • Education level greater than or equal to 8 (in years)
  • For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of first-degree relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM).
  • For the schizophrenia patients group, meeting the DSM5 criteria for schizophrenia.

Exclusion Criteria:

  • Do not consent to be included in the study
  • History of hearing impairments
  • People who cannot read
  • Presence of neurological or somatic diseases
  • Being under tutorship or curatorship

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): NCT04237155


Contacts
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Contact: Lydie Sartelet 0437915531 ext +33 lydie.sartelet@ch-le-vinatier.fr

Locations
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France
Centre Hospitalier le Vinatier Recruiting
Bron, France, 69678
Contact: Marine Mondino    0437915565 ext +33    marine.mondino@ch-le-vinatier.fr   
Contact: Jérôme Brunelin    0437915297 ext +33    jerome.brunelin@ch-le-vinatier.fr   
Principal Investigator: Marine Mondino         
Sub-Investigator: Frédéric Haesebaert         
Sub-Investigator: Jerome Brunelin         
Sponsors and Collaborators
Hôpital le Vinatier

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT04237155    
Other Study ID Numbers: 2019-A02549-48
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
Sorce-monitoring
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders