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- Ensayo clínico NCT06636994
Predicciones anatómicas y funcionales de la capacidad de visión ciega en pacientes con hemianopsia lateral homónima (PRE-SIGHT)
Homonymous lateral hemianopia (HLH) is characterized by loss of vision in half the visual field, and is the most common neurovisual disorder following stroke.
Numerous behavioral and neuroanatomical studies have focused on the phenomenon of blindsight, corresponding to patients' unconscious residual visual capacities in the blind hemifield. Cohort studies of patients have highlighted different types of blindsight, and a low occurrence of the phenomenon initially described: (1) type 1 blindsight (≈12%), unconscious visual abilities; (2) type 2 blindsight, visual abilities associated with sensations in the blind field (≈18%); (3) blindsense, sensations in the blind field without visual abilities (≈30%); and (4) no blindsight (≈40%). The heterogeneity of these blindsight abilities in the HLH population is closely related to patients' neuroanatomical and functional profiles.
In particular, resting-state functional imaging (r-fMRI) and default mode network analysis have highlighted a significant correlation between the degree of inter-hemispheric connection (between the healthy and injured hemispheres) and the rate of spontaneous visual field recovery. To our knowledge, this degree of functional connectivity has not yet been studied in relation to blindsight abilities. However, this functional MRI measurement tool represents a potential predictive factor for patients' residual performance in their blindsight field, in order to assess the level of visuo-cognitive impairment and, ultimately, to adapt care.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amelie Yavchitz, Dr
- Número de teléfono: 0148036454
- Correo electrónico: ayavchitz@for.paris
Copia de seguridad de contactos de estudio
- Nombre: Sadia MEDAOURI
- Número de teléfono: 0148036277
- Correo electrónico: smedaouri@for.paris
Ubicaciones de estudio
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Paris, Francia, 75019
- Hopital Fondation Adolphe de Rothschild
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Contacto:
- clementine GARRIC
- Correo electrónico: clgarric@for.paris
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients over 18 years of age with homonymous lateral hemianopia undergoing cerebral MRI for follow-up and rehabilitation following stroke
Descripción
Inclusion Criteria:
- Subjects aged 18 and over
- with homonymous visual field amputation sequelae of a retrochiasmatic lesion of vascular origin (stroke), including the occipital region (primary visual cortex, optic radiations, associated occipital areas)
- Requires follow-up brain MRI as part of treatment
- Able to perform experimental tasks on computer
- Express consent to participate in the study
- Member or beneficiary of a social security scheme
Exclusion Criteria:
- Severe neuropsychological disorders (language, memory, attention, vigilance, reasoning)
- Severe ophthalmological disorders or visual acuity below 3/10 prior to stroke
- Progressive ophthalmological disorders (cataract or glaucoma) likely to bias measurements
- Major psychiatric or behavioral disorders making care impossible
- Patient benefiting from a legal protection measure
- Pregnant or breast-feeding women (declarative information)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_ONLY
- Perspectivas temporales: CROSS_SECTIONAL
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Description of resting-state functional MRI measurement of the degree of Resting State Functional Connectivity (RSFC) between left and right hemisphere regions.
Periodo de tiempo: DAY 0
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Comparison of the degree of inter-hemispheric Resting State Functional Connectivity between the four patient groups: absence of blindsight, type I blindsight, type II blindsight and blindsense. |
DAY 0
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation between inter-hemispheric functional connectivity and blindsight performance
Periodo de tiempo: DAY 0
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Resting-state functional MRI measurement of the degree of RSFC between left and right hemisphere regions of interest. Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight). |
DAY 0
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Density and intensity of visual and attentional default networks in each type of blindsight
Periodo de tiempo: DAY 0
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Calculation (Graph Theory) of neural network matrices, weighted and created on the basis of correlations of activations in different brain regions during resting-state functional MRI measurement . |
DAY 0
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Blindsight performance according to the laterality of the lesion (left or right hemisphere)
Periodo de tiempo: DAY 0
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Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight) |
DAY 0
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Correlation between the level of inter-hemispheric functional connectivity and blindsight performance
Periodo de tiempo: DAY 0
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Resting-state functional MRI measurement of the degree of Resting State Functional Connectivity (RSFC) between left and right hemisphere regions of interest, blindsight performance assessed by measuring the sensitivity of spatial orientation discrimination (horizontal/vertical) of lines presented in the blindsight field. |
DAY 0
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Correlation between visual default network density and intensity and blindsight performance
Periodo de tiempo: DAY 0
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Computation (Graph Theory) of neural network matrices, weighted and created on the basis of correlations of activations of different brain regions during Resting-state functional MRI measurement. Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight). |
DAY 0
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Correlation between lesion volume and blindsight performance
Periodo de tiempo: DAY 0
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Blindsight performance assessed by measuring the sensitivity of spatial orientation discrimination (horizontal/vertical) of lines presented in the patient's blind field (blindsight). |
DAY 0
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clémentine GARRIC, Integrative Neuroscience and Cognition Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades de los ojos
- Trastornos de la visión
- Trastornos sensoriales
- Ceguera
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Carrera
- Hemianopsia
- Ceguera Cortical
Otros números de identificación del estudio
- CGC_2024_3
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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