Informations générales (source: ClinicalTrials.gov)

NCT04448938 En recrutement IDF
RESting-state Functional MRI in Patients With Optic Neuritis for ANticipation of reCovEry (RESONANCE)
Observational
  • Névrite
  • Névrite optique
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
décembre 2020
juin 2025
29 juin 2024
When patients arrive in the waiting room of the MRI department, patients will be given the briefing note explaining the purpose of the study and how it is going. During the consultation, the radiologist will check the inclusion and non-inclusion criteria, and will take the time to answer all of the patient's questions about the study. If the patient agrees to participate in the research, the investigating doctor will obtain his consent. The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent. A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation. During this visit, an OCT examination (optical coherence tomography), a visual field as well as the measurement of visual acuity will be carried out, in accordance with the treatment usually practiced at the Adolphe de Rothschild Foundation. The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO. The possible existence of visual problems in the subjects of the control group will also be asked to them by interrogation. No eye exams or follow-up visits are planned, and control group participation will end after the MRI scan. Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD Sidney KRYSTAL En recrutement IDF 21/06/2024 13:33:24  Contacter

Critères

Tous
Inclusion Criteria:

- Patients over 18 years of age

- Clinical suspicion of optic neuritis

- Benefiting from an MRI for exploration of optic neuritis

- Affiliate or beneficiary of a social security scheme

- Having received informed information about the study and having given their express
consent to participate in the study



- Contraindication to absolute or relative MRI (in particular, pregnant or
breastfeeding women)

- History of amblyopia

- Any pre-existing pathology leading to a decrease in vision (e.g. retinitis
pigmentosa, AMD, etc.)

- Patient benefiting from a legal protection measure