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NCT Number: NCT06636994

Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Homonymous Hemianopia Blindness Blindness, Cortical Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cortical Blindness Eye Diseases Hemianopia Hemianopsia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stroke Vascular Diseases Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Correlation between inter-hemispheric functional connectivity and blindsight performance

    Time frame: DAY 0

    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).

  2. Density and intensity of visual and attentional default networks in each type of blindsight

    Time frame: DAY 0

    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 .

  3. Blindsight performance according to the laterality of the lesion (left or right hemisphere)

    Time frame: DAY 0

    Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight)

  4. 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.

  5. Correlation between visual default network density and intensity and blindsight performance

    Time frame: DAY 0

    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).

  6. Correlation between lesion volume and blindsight performance

    Time frame: DAY 0

    Blindsight performance assessed by measuring the sensitivity of spatial orientation discrimination (horizontal/vertical) of lines presented in the patient's blind field (blindsight).

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Anatomical and Functional Predictions of Blindsight Capabilities in Post-Stroke Patients With Homonymous Hemianopia (PRE-SIGHT)

Acronym: PRE-SIGHT

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 15, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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