Homonymous HemianopiaPRE-SIGHTNCT06636994
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
An observational study of Homonymous Hemianopia and Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homonymous Hemianopia, Stroke, Cortical Blindness
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Oct 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age with homonymous lateral hemianopia undergoing cerebral MRI for follow-up and rehabilitation following stroke
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital Fondation Adolphe de Rothschild
Paris, 75019
clementine GARRIC, clgarric@for.paris
About this study
Official title: 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.
- Conditions
- Homonymous Hemianopia, Stroke, Cortical Blindness, Hemianopia
- Medical subject headings
- Hemianopsia, Stroke, Blindness, Cortical
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of resting-state functional MRI measurement of the degree of Resting State Functional Connectivity (RSFC) between left and right hemisphere regions.
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.
Measured: DAY 0
Secondary outcomes (6)
Correlation between inter-hemispheric functional connectivity and blindsight performance
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).
Measured: DAY 0
Density and intensity of visual and attentional default networks in each type of blindsight
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 .
Measured: DAY 0
Blindsight performance according to the laterality of the lesion (left or right hemisphere)
Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight)
Measured: DAY 0
Correlation between the level of inter-hemispheric functional connectivity and blindsight performance
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.
Measured: DAY 0
Correlation between visual default network density and intensity and blindsight performance
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).
Measured: DAY 0
Correlation between lesion volume and blindsight performance
Blindsight performance assessed by measuring the sensitivity of spatial orientation discrimination (horizontal/vertical) of lines presented in the patient's blind field (blindsight).
Measured: DAY 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homonymous HemianopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Clémentine GARRIC, Principal investigator, Integrative Neuroscience and Cognition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636994
- Sponsor's protocol ID
- CGC_2024_3
- Acronym
- PRE-SIGHT
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No