- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02874482
Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia (SAILLANCE1)
Study of Cognitive and Emotional Factors Influencing the Visual Exploration Among Patients With Schizophrenia
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Lille, Frankrig, 59037
- University Hospital, Lille
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Patients with schizophrenia
30 patients with schizophrenia (diagnosis based on the standard DSM criteria)
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Kontrolelementer
30 sunde kontroller uden nogen psykiatrisk eller neurologisk diagnose
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
response time
Tidsramme: 42 months
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The explicit response of the participants will be measure behaviourally by response time before the detection of neutral stimuli.
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42 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
sensitivity index
Tidsramme: 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.
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42 months
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implicit response
Tidsramme: 42 months
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The implicit response will be measure by the localization and duration of fixations
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42 months
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emotional response
Tidsramme: 42 months
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The emotional response will be measure by the localization, duration of fixations and performances for the detection of emotional stimuli
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42 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Guillaume VAIVA, University Hospital, Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013_19.1
- 2013-A01497-38 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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