Magnetic Resonance Imaging of Cerebral Connectivity and Volume in Neurodegeneration and Glaucoma (EVOLUTION)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Glaucoma is a neurodegenerative disease characterised by a progressive loss of retinal ganglion cells, typical optic neuropathy with a loss of visual field and visual function. High intraocular pressure is it's main risk factor, but the patophysiology hasn't been clearely understood, as there exist forms with normal ocular pressure (NTG - normal tension glaucoma) or mixed forms. Studies have shown that the degeneration is not limited to retinal ganglion cells only, but rather it affects the whole visual pathway including the occipital cortex. The ENVOL study has been able to show microstructural alterations of the optic radiations in glaucoma. Furthermore, glaucomatous patients have been found to be more at risk of developing other neurodegenerative diseases, namely Alzheimer's disease.
The EVOLUTION study is set to repeat 3T brain MRI in patients previously enrolled in ENVOL in order to compare brain microstructure between glaucomatous and matched healthy subjects, assess their ocular status and glaucoma progression over time, as well as compare them with orignal imagery from 10 years prior.
gression over time, as well as compare them with orignal imagery from 10 years prior.
Study subjects will undergo a typical non-invasive ophthalmic screening comprised of best-corrected visual acuity testing, slit-lamp biomicroscopy, gonioscopy, indirect opthalmoscopy, fundus photography, 30° visual field testing and optical coherence tomography of the optic nerve. They will also answer a questionnaire concerning their medical treatment, cardiovascular health and tobacco use. Next, they will undergo a 3T brain MRI comprised of a T1-weighted 3D morphological sequence, 3D FLAIR, resting state fMRI and diffusion tensor imaging.
fMRI and diffusion tensor imaging
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cedrick Schweitzer, MD, PhD
- Número de teléfono: +335 56 79 55 30
- Correo electrónico: cedric.schweitzer@chu-bordeaux.fr
Ubicaciones de estudio
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Bordeaux, Francia
- Reclutamiento
- CHU Bordeaux
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Contacto:
- Cedrick Schweitzer, MD, PhD
- Número de teléfono: +335 56 79 55 30
- Correo electrónico: cedric.schweitzer@chu-bordeaux.fr
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- having been previously included and completed the ENVOL study
- Ability and willingness to provide informed consent
- Having a valid health insurance in France
In glaucoma group :
- Glaucomatous optic neuropathy, being able to be graded by the vertical C/D ratio
- Open angle on gonioscopy in a dark-room testing according to Shaffer's classification (grade 3 or grade 4)
Visual field impairement (at least one of the following) :
- 3 adjacent points with at least 5dB loss
- one point with a loss of 10dB
- a difference of at least 10 dB for 2 adjacent points on either side of the horizontal meridian of the nasal visual field
- Mini Mental State Score of at least 28
In control group :
- No personal or family history of glaucoma or ocular hypertension (IOP > 21 mmHg)
- Open angle on gonioscopy in a dark-room testing according to Shaffer's classification (grade 3 or grade 4)
- Intraocular pressure of ≤ 21 mmHg
- Absence of glaucomatous neuropathy
- Normal visual field
Exclusion Criteria:
- Inability/unwillingness to provide informed consent
- Other causes of ocular hypertension (trauma, uveitis)
- Non-glaucomatous optic neuropathy (infectious, inflammatory, compressive, ischemic)
- Unreliable visual field (>15% false positives, >33% false negatives or >20% loss of fixation)
- Severe corneal pathology preventing access to fundus, visual field testing or altering ocular tonometry
- Contraindications to MRI testing (pacemakers or neurosensory stimulators, cochlear implants, ferromagnetic foreign bodies, claustrophobia)
- Patients under guardianship or other form of legal protection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Patient with glaucoma
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Resonancia magnética
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Comparador activo: Patient without glaucoma
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Resonancia magnética
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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structural and functional connectivity matrices
Periodo de tiempo: Baseline
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10-year whole brain comparison of structural and functional connectivity matrices (Hub Disruption Index) on 3T MRI in glaucoma patients and controls from the ENVOL study
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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microstructural changes
Periodo de tiempo: Baseline
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Comparison of microstructural changes on diffusion MRI within the whole brain and by specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex) between the 2 groups (voxel-by-voxel analysis)
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Baseline
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cerebral volumes
Periodo de tiempo: Baseline
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Comparison of cerebral volumes (total volume of cerebral parenchyma), and volumes of specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex) between the 2 groups
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Baseline
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Evolution of the above parameters
Periodo de tiempo: Baseline
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Comparison of evolution of the above parameters over a 10-year period between the ENVOL study and EVOLUTION follow-up study (microstructural changes on diffusion MRI within the whole brain and by specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex), cerebral volumes (total volume of cerebral parenchyma), and volumes of specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex)).
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Baseline
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Demographic factors
Periodo de tiempo: Baseline
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Identication of demographic that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
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Baseline
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Ophthalmological factors
Periodo de tiempo: Baseline
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Ophthalmological factors, notably characterization of the type of glaucoma (normal pressure, high pressure) that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- CHUBX 2024/90
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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