NFL OCT
What it found
No result yet.
What was tested
Treatment tested
- Brain MRI
- Spinal Cord MRI
- Retinal imaging
What it measured
Main measures
Change in serum Neurofilament Light Chain serum levels since baseline
Baseline; 1 year
Blood or spinal fluid markersChange in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline
Baseline; 1 year
Blood or spinal fluid markersChange in Ganglion Cell Complex thickness since baseline
Baseline; 1 year
Retina scans (OCT)Change in whole brain volume since baseline
Baseline; 1 year
MRI lesionsBrain volume lossExpanded Disability Status Scale
Baseline
Disability progressionExpanded Disability Status Scale
3 years
Disability progression
Other measures (165)
Whole brain volume
Inclusion
MRI lesionsBrain volume lossWhole brain volume
6 Months
MRI lesionsBrain volume lossWhole brain volume
1 Year
MRI lesionsBrain volume lossWhole brain volume
2 years
MRI lesionsBrain volume lossWhole brain volume
3 Years
MRI lesionsBrain volume lossWhole brain volume
4 Years
MRI lesionsBrain volume lossWhole brain volume
5 years
MRI lesionsBrain volume lossWhole brain volume
any relapse (max 5 years)
MRI lesionsBrain volume lossExpanded Disability Status Scale
Inclusion
Disability progressionExpanded Disability Status Scale
6 Months
Disability progression
Who could take part
Relapsing and progressive · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jun 2019
Main results due
Mar 2027
Finished
Mar 2027
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