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Exploration of Neural Bases in Social Cognition (IRM-COG)

4. februar 2015 oppdatert av: University Hospital, Caen

An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.

Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05).

Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.

Studieoversikt

Detaljert beskrivelse

Social cognition neural basis. Impairment of the "social brain" in schizophrenia

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Normandy
      • Caen, Normandy, Frankrike, 14000
        • Rekruttering
        • Centre Hospitalier Universitaire
        • Ta kontakt med:
          • Perrine Brazo, MD-PhD
          • Telefonnummer: 0033231065018
        • Ta kontakt med:
        • Hovedetterforsker:
          • Perrine BRAZO, MD-PhD
        • Hovedetterforsker:
          • Sonia DOLLFUS, MD-PhD
        • Hovedetterforsker:
          • Pascal DELAMILLIEURE, MD-PhD
        • Hovedetterforsker:
          • Vincent MARZLOFF, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects aged from 18 to 60 years old
  • who have signed a consent and, if there is one, whose legal representant has signed a consent

    1)For healthy subjects:

  • without any psychiatric affection (Mini International Neuropsychiatric Interview)

    2)For patients

  • meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder

Exclusion Criteria:

  • pregnant woman
  • neurological affection
  • medical objection to Magnetic Resonance Imagery (MRI)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Patients with schizophrenia

Twenty patients suffering from schizophrenia (DSM-IV-R), with medication and medical care. No recent relapse of the psychotic disease, nor change in medications.

No neurological comorbidity.

After anatomic scans, each subject will go through the fMRI social cognition task.

fMRI social cognition task : each subject will go through 3 runs of a fMRI paradigm, first one verbal then two visual runs, which are meant to activate the theory of mind network.
Andre navn:
  • Philips 3 Tesla fMRI
Annen: Healthy subjects

Twenty healthy subjects (no mental or neurological disease)

After anatomic scans, each subject will go through the fMRI social cognition task.

fMRI social cognition task : each subject will go through 3 runs of a fMRI paradigm, first one verbal then two visual runs, which are meant to activate the theory of mind network.
Andre navn:
  • Philips 3 Tesla fMRI

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
Tidsramme: Day 1 for individual analysis. Up to 24 months for group analysis.
The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05)
Day 1 for individual analysis. Up to 24 months for group analysis.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Tidsramme: Day 1 for individual analysis. Up to 24 months for group analysis.
Using the previous social cognition ecological task, BOLD signal variations at a high statistical correction ratio (p<0.05) of 20 patients with schizophrenia will be compared to those of 20 matched healthy subjects.
Day 1 for individual analysis. Up to 24 months for group analysis.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Perrine BRAZO, MD-PhD, University of Caen, UMR 6301 ISTCT ISTS group; CNRS UMR 6301 ISTCT GIP Cyceron; CEA UMR 6301 ISTCT; CHU de Caen, Department of psychiatry, Centre Esquirol

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2013

Primær fullføring (Forventet)

1. september 2015

Studiet fullført (Forventet)

1. september 2015

Datoer for studieregistrering

Først innsendt

12. september 2013

Først innsendt som oppfylte QC-kriteriene

8. april 2014

Først lagt ut (Anslag)

10. april 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. februar 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • RCB 2013-A00064-41

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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