Magnetic Resonance Imaging of Cerebral Connectivity and Volume in Neurodegeneration and Glaucoma (EVOLUTION)
Aperçu de l'étude
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Cedrick Schweitzer, MD, PhD
- Numéro de téléphone: +335 56 79 55 30
- E-mail: cedric.schweitzer@chu-bordeaux.fr
Lieux d'étude
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Bordeaux, France
- Recrutement
- CHU Bordeaux
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Contact:
- Cedrick Schweitzer, MD, PhD
- Numéro de téléphone: +335 56 79 55 30
- E-mail: cedric.schweitzer@chu-bordeaux.fr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Patient with glaucoma
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IRM
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Comparateur actif: Patient without glaucoma
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IRM
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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structural and functional connectivity matrices
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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microstructural changes
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CHUBX 2024/90
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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