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Trials / Active Not Recruiting

Active Not RecruitingNCT04860947

Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients

Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBrain MRI* Axial DWI with ADC card * Axial 2D TSE T2/DP or 3DT2 * Gadolinium injection (0.1 mmol/kg) * 3D Fluid-attenuated inversion recovery * 3D T1 with Gadolinium injection.
DIAGNOSTIC_TESTSpinal Cord MRISagittal T2 Sagittal T1 with Gadolinium injection
DIAGNOSTIC_TESTRetinal imagingspectral-domain high definition optical coherence tomography

Timeline

Start date
2019-06-25
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2021-04-27
Last updated
2024-02-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04860947. Inclusion in this directory is not an endorsement.