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Recruiting NCT04648124

VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies

Observational Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IRMf-r (séquence resting state).
Who it may be relevant to
Registry conditions: Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.

Interventions

  • Device IRMf-r (séquence resting state)
    Functional MRI of functional brain networks

Primary outcome measures

  • Localization and characterization of neural networks [Time frame: baseline]
  • Evolution of neuronal networks after retinal implantation [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Patient over 18 years old
  • Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique
  • Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months
  • Express consent to participate in the study
  • Affiliate or beneficiary of a social security scheme

Exclusion criteria

  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman
  • Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
  • Other additional ocular pathology that can significantly affect vision
  • Recent eye surgery less than 3 months old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Fondation Adolphe de Rothschild — Paris

Identifiers

NCT: NCT04648124 · ALR_2020_30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗