- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04237155
French Source-monitoring Task (SOUMO)
Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Bron, Frankrig, 69678
- Rekruttering
- Centre Hospitalier le Vinatier
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Healthy controls involved in step 1
30 healthy individuals will complete a verbal material scoring questionnaire
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Subjects will complete a verbal material scoring questionnaire
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Andet: Patients with schizophrenia involved in step 1
30 patients with schizophrenia will complete a verbal material scoring questionnaire
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Subjects will complete a verbal material scoring questionnaire
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Andet: 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
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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
|
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Andet: 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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Source-monitoring performances
Tidsramme: one day
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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).
|
one day
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019-A02549-48
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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