Multiple Sclerosis
Conditions
Keywords
GFAP, NfL
Brief 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.
Interventions
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 MRI
Sagittal T2 Sagittal T1 with Gadolinium injection
DIAGNOSTIC_TESTRetinal imaging
spectral-domain high definition optical coherence tomography
Sponsors
Institut de Recherches en Biothérapie
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Neurofilament Light Chain serum levels since baseline | Baseline; 1 year | pg/mL; measured by digital ELISA |
| Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline | Baseline; 1 year | pg/mL; measured by digital ELISA |
| Change in Ganglion Cell Complex thickness since baseline | Baseline; 1 year | Measured by Optical Coherence Tomography |
| Change in whole brain volume since baseline | Baseline; 1 year | Assessed by MRI |
| Expanded Disability Status Scale | Baseline | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grey matter atrophy | Inclusion | assessed by MRI |
| White matter atrophy | Inclusion | assessed by MRI |
| Thalamic atrophy | Inclusion | assessed by MRI |
| Disease modifying drugs classification | Inclusion | Drug class (1st, 2nd or 3rd line) |
| serum NfL levels | 6 Months | pg/mL; measured by digital ELISA |
| serum GFAP levels | 6 Months | pg/mL; measured by digital ELISA |
| Multiple Sclerosis Functional Composite | Inclusion | 21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT) |
| Time to walk 100 meters | Inclusion | Seconds |
| 2 Minute walking distance | Inclusion | Meters |
| Whole brain volume | Inclusion | assessed by MRI |
| Cognitive evaluation | Inclusion | Brief International Cognitive Assessment for Multiple Sclerosis |
| Health-related quality of life | Inclusion | EQ-5D-5L |
| Impact of MS on daily life | Inclusion | Multiple Sclerosis Impact Scale (MSIS-29) |
| Fatigue | Inclusion | Modified Fatigue Impact Scale |
| Visual acuity | Inclusion | 0= low, 10= good |
| Low contrast visual acuity | Inclusion | 0= low, 10 good |
| Relapse description | At relapse (maximum 5 years) | monofocal, plurifocal |
| Number of new lesions | At relapse (maximum 5 years) | Measured by MRI |
| Cognitive Impairment | Inclusion | Symbol Digit Modalities Test |
| Expanded Disability Status Scale | Inclusion | Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability) |
| Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness | Inclusion | assessed by Optical Coherence Tomography |
| Gadolinium-enhanced lesions | Inclusion | assessed by MRI |
| T2 lesion volume, | Inclusion | assessed by MRI |
Countries
France
Outcome results
None listed