- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06636994
Previsioni anatomiche e funzionali delle capacità visive nei pazienti con emianopsia laterale omonima (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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Amelie Yavchitz, Dr
- Numero di telefono: 0148036454
- Email: ayavchitz@for.paris
Backup dei contatti dello studio
- Nome: Sadia MEDAOURI
- Numero di telefono: 0148036277
- Email: smedaouri@for.paris
Luoghi di studio
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Paris, Francia, 75019
- Hopital Fondation Adolphe de Rothschild
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Contatto:
- clementine GARRIC
- Email: clgarric@for.paris
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients over 18 years of age with homonymous lateral hemianopia undergoing cerebral MRI for follow-up and rehabilitation following stroke
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_ONLY
- Prospettive temporali: CROSS_SECTIONAL
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlation between inter-hemispheric functional connectivity and blindsight performance
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Clémentine GARRIC, Integrative Neuroscience and Cognition Center
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Malattie degli occhi
- Disturbi della vista
- Disturbi della sensibilità
- Cecità
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Ictus
- Emianopsia
- Cecità, corticale
Altri numeri di identificazione dello studio
- CGC_2024_3
Informazioni su farmaci e dispositivi, documenti di studio
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