Skip to content

Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination

Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03268096
Acronym
DB-SEP15
Enrollment
182
Registered
2017-08-31
Start date
2017-05-03
Completion date
2021-11-03
Last updated
2022-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging, Multiple Sclerosis, Pathologic Processes, Prognosis, Tomography, Optical Coherence

Brief summary

Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is essential to guide the therapeutic management. However, it remains partial and concerns above all data collected during the first years of the disease. The evolution towards disability can only be assessed after a follow-up of more than 10 years and does not depend solely on the initial inflammatory activity of the disease. We propose to realize a standardized clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after the first clinical manifestation of the disease. Clinical and paraclinical assessment will consist in the realization of additional MRI sequences in order to obtain more precise information on cerebral lesions (unconventional parameters). Optical coherence tomography (new generation device) will also be performed on both eyes to describe the thickness of the different layers of the retina. A clinical evaluation will be performed with the Expanded Disability Status Scale (EDSS). This study aims: 1. to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability) 2. to explore the associations between MRI parameters, those measured with OCT and clinical characteristics (disability) 3. to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)

Interventions

DEVICECerebral MRI and Optical Coherence Tomography

Clinical and paraclinical assessment (cerebral MRI and Optical Coherence Tomography) will be carried out on the same day. Paraclinical evaluation consists in the realization of additional MRI sequences in order to obtain more precise information on brain lesions (unconventional parameters). An optical coherence tomography will also be performed for both eyes to describe the thickness of the different layers of the retina.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* First episode of demyelination occurred at least 10 years ago * Hospitalized in the neurology department during this episode * Insured with a social security scheme * Having given his consent to participate in the study

Exclusion criteria

* Contraindications to 3 Tesla MRI and injection of contrast media * Benefiting from a legal protection measure * Pregnant or nursing mother

Design outcomes

Primary

MeasureTime frameDescription
Disability assessed with EDSS (Expanded Disability Status Scale)BaselineDisability assessment will be carried out using the EDS (Expanded Disability Status) Scale. This scale ranges from 0 to 10. Binary or ordered variables will be considered with various thresholds (for example, a score equal to 3 corresponds to moderate disorders ; a score equal to 6 corresponds to major disorders (need of a stick to walk 100 meters)).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026