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 (NFL OCT)

Centre Hospitalier Universitaire de Nīmes

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Diagnostic Test: Brain MRI; Diagnostic Test: Spinal Cord MRI; Diagnostic Test: Retinal imaging

Study type: Observational

Funder types: Other

Identifiers

NCT04860947

CIVI/2018/ET-01

2018-A03152-53 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

MS patients

Treatment:

Diagnostic Test: Retinal imaging

Diagnostic Test: Spinal Cord MRI

Diagnostic Test: Brain MRI