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

N/AActive Not RecruitingNCT04860947

Centre Hospitalier Universitaire de Nīmes200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Multiple Sclerosis

Interventions

Brain MRIDIAGNOSTIC_TEST

* 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.

Spinal Cord MRIDIAGNOSTIC_TEST

Sagittal T2 Sagittal T1 with Gadolinium injection

Retinal imagingDIAGNOSTIC_TEST

spectral-domain high definition optical coherence tomography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient has been correctly informed. * The patient must have given their informed and signed consent. * The patient must be insured or beneficiary of a health insurance plan. * The patient is at least (≥)18 years old. * The patient has experienced a CIS, has currently a RRMS or progressive MS with: * Less than 10 years of disease duration; * With or without DMD; * EDSS score 0 - 7.0. Exclusion Criteria: * The patient is in an exclusion period determined by a previous study. * The patient is under judicial protection. * The patient refuses to sign the consent. * It is impossible to correctly inform the patient (Inability to understand the study, language problem). * The patient is pregnant or breast-feeding. * Patient has a bilateral optic neuritis or other significant ophthalmological antecedent. * Patient with MRI contra-indications. * patient has a contraindication to gadolinium injection * The patient has bilateral optic neuritis or other significant ophthalmological antecedent * Patient is having a relapse or has had a relapse in the last 3 months * The patient has a severe psychiatric illness * The patient has severe chronic alcoholism

Locations (1)

CHU de Nimes

Nîmes, France

Outcomes

Primary Outcomes

Change in serum Neurofilament Light Chain serum levels since baseline

pg/mL; measured by digital ELISA

Time frame: Baseline; 1 year

Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline

pg/mL; measured by digital ELISA

Time frame: Baseline; 1 year

Change in Ganglion Cell Complex thickness since baseline

Measured by Optical Coherence Tomography

Time frame: Baseline; 1 year

Change in whole brain volume since baseline

Assessed by MRI

Time frame: Baseline; 1 year

Expanded Disability Status Scale

Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)

Time frame: Baseline

Expanded Disability Status Scale

Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)

Time frame: 3 years

Secondary Outcomes

Whole brain volume

assessed by MRI

Time frame: Inclusion

Whole brain volume

assessed by MRI

Time frame: 6 Months

Whole brain volume

assessed by MRI

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.