NCT06636994

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
43mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Nov 2024Dec 2029

First Submitted

Initial submission to the registry

August 9, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 21, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

August 9, 2024

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

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.

    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

Secondary Outcomes (6)

  • Correlation between inter-hemispheric functional connectivity and blindsight performance

    DAY 0

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

    DAY 0

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

    DAY 0

  • Correlation between the level of inter-hemispheric functional connectivity and blindsight performance

    DAY 0

  • Correlation between visual default network density and intensity and blindsight performance

    DAY 0

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years of age with homonymous lateral hemianopia undergoing cerebral MRI for follow-up and rehabilitation following stroke

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

HemianopsiaStrokeBlindness, Cortical

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Clémentine GARRIC

    Integrative Neuroscience and Cognition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

October 15, 2024

Study Start

November 21, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations