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

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Diagnostic Test: Brain MRI; Diagnostic Test: Spinal Cord MRI; Diagnostic Test: Retinal imaging

• Registration Number: NCT04860947
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MS patients	Retinal imaging	-
MS patients	Spinal Cord MRI	-
MS patients	Brain MRI	-

Primary Outcome Measures

Name	Time	Method
Change in serum Neurofilament Light Chain serum levels since baseline	Baseline; 1 year	pg/mL; measured by digital ELISA
Expanded Disability Status Scale	3 years	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Change in Ganglion Cell Complex thickness since baseline	Baseline; 1 year	Measured by Optical Coherence Tomography
Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline	Baseline; 1 year	pg/mL; measured by digital ELISA
Change in whole brain volume since baseline	Baseline; 1 year	Assessed by MRI

Secondary Outcome Measures

Name	Time	Method
Grey matter atrophy	Any relapse (maximum 5 Years)	assessed by MRI
Multiple Sclerosis Functional Composite	Any relapse (maximum 5 years)	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	Any relapse (maximum 5 years)	Seconds
2 Minute walking distance	Any relapse (maximum 5 years)	Meters
Cognitive Impairment	Any relapse (maximum 5 years)	Symbol Digit Modalities Test
Thalamic atrophy	Any relapse (maximum 5 years)	assessed by MRI
serum NfL levels	Any relapse (maximum 5 years)	pg/mL; measured by digital ELISA
serum GFAP levels	Any relapse (maximum 5 years)	pg/mL; measured by digital ELISA
White matter atrophy	Any relapse (maximum 5 years)	assessed by MRI
Visual acuity	Any relapse (maximum 5 years)	0= low, 10 good
Low contrast visual acuity	Any relapse (maximum 5 years)	0= low, 10 good
Relapse description	At relapse (maximum 5 years)	monofocal, plurifocal
Whole brain volume	any relapse (max 5 years)	assessed by MRI
Disease modifying drugs classification	until end of study (5 years)	Drug class (1st, 2nd or 3rd line)
Impact of MS on daily life	Any relapse (maximum 5 years)	Multiple Sclerosis Impact Scale (MSIS-29)
Fatigue	Any relapse (maximum 5 years)	Modified Fatigue Impact Scale
Number of new lesions	At relapse (maximum 5 years)	Measured by MRI
Expanded Disability Status Scale	Any relapse (Maximum 5 years)	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	Any relapse (maximum 5 Years)	assessed by Optical Coherence Tomography
Gadolinium-enhanced lesions	Any relapse (Maximum 5 Years)	assessed by MRI
T2 lesion volume,	Any relapse (maximum 5 years)	assessed by MRI
Cognitive evaluation	Any relapse (maximum 5 years)	Brief International Cognitive Assessment for Multiple Sclerosis
Health-related quality of life	Any relapse (maximum 5 years)	EQ-5D-5L

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France