- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06636994
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia (PRE-SIGHT)
Anatomical and Functional Predictions of Blindsight Capabilities in Post-Stroke Patients With Homonymous Hemianopia (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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Paris, France, 75019
- Hopital Fondation Adolphe de Rothschild
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
Time Frame: 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.
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DAY 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between inter-hemispheric functional connectivity and blindsight performance
Time Frame: 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
Time Frame: 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 .
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DAY 0
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Blindsight performance according to the laterality of the lesion (left or right hemisphere)
Time Frame: 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)
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DAY 0
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Correlation between the level of inter-hemispheric functional connectivity and blindsight performance
Time Frame: DAY 0
|
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
Time Frame: 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).
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DAY 0
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Correlation between lesion volume and blindsight performance
Time Frame: 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).
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DAY 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Clémentine GARRIC, Integrative Neuroscience and Cognition Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGC_2024_3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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