EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients (EXPRESONREA)
EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.
Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.
Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient. However the correlation of this P3 wave and neurologic prognosis is still imperfect and depends on the etiology of the DOC.
In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices involves more widespread brain areas than neutral voices processing.
Here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. The investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Estelle Pruvost-Robieux, MD
- Número de teléfono: + 33 1 45 65 81 89
- Correo electrónico: e.pruvost@ghu-paris.fr
Copia de seguridad de contactos de estudio
- Nombre: Martine Gavaret, Professor
- Número de teléfono: + 33 1 45 65 81 89
- Correo electrónico: m.gavaret@ghu-paris.fr
Ubicaciones de estudio
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Paris, Francia, 75014
- Reclutamiento
- GHU Paris Psychiatrie Neurosciences
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Contacto:
- Estelle Pruvost-Robieux, MD
- Número de teléfono: +33 1 45 65 81 89
- Correo electrónico: e.pruvost@ghu-paris.fr
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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:
- Age over 18
- Disorder of consciousness defined as :
Glasgow coma scale < 8 or >8 but
- eyes opening to pain only
- No response to basic command
- Available neuro-imagery (CT-scan or MRI)
- Normal temperature (no fever or hypothermia)
- Normal blood pressure during neurophysiologic evaluation
- Given consent from relatives
Exclusion Criteria:
- Brain death
- Known deafness
- Severe sepsis uncontrolled during neurophysiologic evaluation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Whole group
The whole group listen successively the 3 paradigms :
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Evoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months
Periodo de tiempo: 3 months from DOC evaluation
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Determination of the positive predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Negative predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Periodo de tiempo: 3 months from DOC evaluation
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Determination of the negative predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Sensitivity of P3a responses occurences to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Periodo de tiempo: 3 months from DOC evaluation
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Determination of the sensibility of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Specificity of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Periodo de tiempo: 3 months from DOC evaluation
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Determination of the specificity of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Periodo de tiempo: 7, 14 and 28 days from DOC evaluation
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Determination of the negative predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Periodo de tiempo: 7, 14 and 28 days from DOC evaluation
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Determination of the positive predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
Periodo de tiempo: 7, 14 and 28 days from DOC evaluation
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Determination of the sensibility of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Periodo de tiempo: 7, 14 and 28 days from DOC evaluation
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Determination of the specificity of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Periodo de tiempo: 3 months
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Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Periodo de tiempo: 3 months
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Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
Periodo de tiempo: 3 months
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Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Periodo de tiempo: 3 months
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Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Periodo de tiempo: 3 months
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Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices
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3 months
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Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Periodo de tiempo: 3 months
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Latencies of P3a waves recorded with own name uttered by expressive and neutral voices
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3 months
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Colaboradores e Investigadores
Patrocinador
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Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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Última verificación
Más información
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Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020-A00747-32
Información sobre medicamentos y dispositivos, documentos del estudio
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