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- Ensayo clínico NCT02110017
Exploration of Neural Bases in Social Cognition (IRM-COG)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Normandy
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Caen, Normandy, Francia, 14000
- Reclutamiento
- Centre Hospitalier Universitaire
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Contacto:
- Perrine Brazo, MD-PhD
- Número de teléfono: 0033231065018
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Contacto:
- Vincent B Marzloff, MD
- Número de teléfono: 0033231064424
- Correo electrónico: marzloff-v@chu-caen.fr
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Investigador principal:
- Perrine BRAZO, MD-PhD
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Investigador principal:
- Sonia DOLLFUS, MD-PhD
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Investigador principal:
- Pascal DELAMILLIEURE, MD-PhD
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Investigador principal:
- Vincent MARZLOFF, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: 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.
Otros nombres:
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Otro: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Periodo de tiempo: 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.
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Day 1 for individual analysis. Up to 24 months for group analysis.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RCB 2013-A00064-41
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Ensayos clínicos sobre fMRI social cognition task
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NYU Langone HealthNational Institute of Mental Health (NIMH)Reclutamiento