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

Multiple Sclerosis Clinical Trial

— NFL OCT  

Official title:

Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04860947
• Other study ID #: CIVI/2018/ET-01
• Secondary ID: 2018-A03152-53
• Status: Active, not recruiting
• Start date: June 25, 2019
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Brain 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.
• Spinal Cord MRI
Sagittal T2 Sagittal T1 with Gadolinium injection
• Retinal imaging
spectral-domain high definition optical coherence tomography

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Institut de Recherches en Biothérapie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum Neurofilament Light Chain serum levels since baseline	pg/mL; measured by digital ELISA	Baseline; 1 year
Primary	Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline	pg/mL; measured by digital ELISA	Baseline; 1 year
Primary	Change in Ganglion Cell Complex thickness since baseline	Measured by Optical Coherence Tomography	Baseline; 1 year
Primary	Change in whole brain volume since baseline	Assessed by MRI	Baseline; 1 year
Primary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	Baseline
Primary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	3 years
Secondary	Whole brain volume	assessed by MRI	Inclusion
Secondary	Whole brain volume	assessed by MRI	6 Months
Secondary	Whole brain volume	assessed by MRI	1 Year
Secondary	Whole brain volume	assessed by MRI	2 years
Secondary	Whole brain volume	assessed by MRI	3 Years
Secondary	Whole brain volume	assessed by MRI	4 Years
Secondary	Whole brain volume	assessed by MRI	5 years
Secondary	Whole brain volume	assessed by MRI	any relapse (max 5 years)
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	Inclusion
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	6 Months
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	1 year
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	18 months
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	2 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	2.5 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	3 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	3.5 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	4 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	4.5 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	5 years
Secondary	Expanded Disability Status Scale	Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)	Any relapse (Maximum 5 years)
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	Inclusion
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	6 Months
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	1 Year
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	18 Months
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	2 years
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	3 Years
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	4 Years
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	5 Years
Secondary	Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness	assessed by Optical Coherence Tomography	Any relapse (maximum 5 Years)
Secondary	Gadolinium-enhanced lesions	assessed by MRI	Inclusion
Secondary	Gadolinium-enhanced lesions	assessed by MRI	6 Months
Secondary	Gadolinium-enhanced lesions	assessed by MRI	1 Year
Secondary	Gadolinium-enhanced lesions	assessed by MRI	2 years
Secondary	Gadolinium-enhanced lesions	assessed by MRI	3 Years
Secondary	Gadolinium-enhanced lesions	assessed by MRI	4 Years
Secondary	Gadolinium-enhanced lesions	assessed by MRI	5 Years
Secondary	Gadolinium-enhanced lesions	assessed by MRI	Any relapse (Maximum 5 Years)
Secondary	T2 lesion volume,	assessed by MRI	Inclusion
Secondary	T2 lesion volume,	assessed by MRI	6 Months
Secondary	T2 lesion volume,	assessed by MRI	1 Year
Secondary	T2 lesion volume,	assessed by MRI	2 years
Secondary	T2 lesion volume,	assessed by MRI	3 Years
Secondary	T2 lesion volume,	assessed by MRI	4 Years
Secondary	T2 lesion volume,	assessed by MRI	5 years
Secondary	T2 lesion volume,	assessed by MRI	Any relapse (maximum 5 years)
Secondary	Grey matter atrophy	assessed by MRI	Inclusion
Secondary	Grey matter atrophy	assessed by MRI	6 Months
Secondary	Grey matter atrophy	assessed by MRI	1 Year
Secondary	Grey matter atrophy	assessed by MRI	2 years
Secondary	Grey matter atrophy	assessed by MRI	3 Years
Secondary	Grey matter atrophy	assessed by MRI	4 Years
Secondary	Grey matter atrophy	assessed by MRI	5 Years
Secondary	Grey matter atrophy	assessed by MRI	Any relapse (maximum 5 Years)
Secondary	White matter atrophy	assessed by MRI	Inclusion
Secondary	White matter atrophy	assessed by MRI	6 Months
Secondary	White matter atrophy	assessed by MRI	1 Year
Secondary	White matter atrophy	assessed by MRI	2 years
Secondary	White matter atrophy	assessed by MRI	3 Years
Secondary	White matter atrophy	assessed by MRI	4 Years
Secondary	White matter atrophy	assessed by MRI	5 years
Secondary	White matter atrophy	assessed by MRI	Any relapse (maximum 5 years)
Secondary	Thalamic atrophy	assessed by MRI	Inclusion
Secondary	Thalamic atrophy	assessed by MRI	6 Months
Secondary	Thalamic atrophy	assessed by MRI	1 Year
Secondary	Thalamic atrophy	assessed by MRI	2 years
Secondary	Thalamic atrophy	assessed by MRI	3 Years
Secondary	Thalamic atrophy	assessed by MRI	4 Years
Secondary	Thalamic atrophy	assessed by MRI	5 years
Secondary	Thalamic atrophy	assessed by MRI	Any relapse (maximum 5 years)
Secondary	Disease modifying drugs classification	Drug class (1st, 2nd or 3rd line)	Inclusion
Secondary	Disease modifying drugs classification	Drug class (1st, 2nd or 3rd line)	until end of study (5 years)
Secondary	serum NfL levels	pg/mL; measured by digital ELISA	6 Months
Secondary	serum GFAP levels	pg/mL; measured by digital ELISA	6 Months
Secondary	serum NfL levels	pg/mL; measured by digital ELISA	2 years
Secondary	serum GFAP levels	pg/mL; measured by digital ELISA	2 years
Secondary	serum NfL levels	pg/mL; measured by digital ELISA	3 years
Secondary	serum GFAP levels	pg/mL; measured by digital ELISA	3 years
Secondary	serum NfL levels	pg/mL; measured by digital ELISA	4 years
Secondary	serum GFAP levels	pg/mL; measured by digital ELISA	4 years
Secondary	serum NfL levels	pg/mL; measured by digital ELISA	5 years
Secondary	serum GFAP levels	pg/mL; measured by digital ELISA	5 years
Secondary	serum NfL levels	pg/mL; measured by digital ELISA	Any relapse (maximum 5 years)
Secondary	serum GFAP levels	pg/mL; measured by digital ELISA	Any relapse (maximum 5 years)
Secondary	Multiple Sclerosis Functional Composite	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)	Inclusion
Secondary	Multiple Sclerosis Functional Composite	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)	6 Months
Secondary	Multiple Sclerosis Functional Composite	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)	1 Year
Secondary	Multiple Sclerosis Functional Composite	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)	2 years
Secondary	Multiple Sclerosis Functional Composite	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)	3 years
Secondary	Multiple Sclerosis Functional Composite	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)	4 years
Secondary	Multiple Sclerosis Functional Composite	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)	5 years
Secondary	Multiple Sclerosis Functional Composite	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)	Any relapse (maximum 5 years)
Secondary	Time to walk 100 meters	Seconds	Inclusion
Secondary	Time to walk 100 meters	Seconds	6 Months
Secondary	Time to walk 100 meters	Seconds	1 Year
Secondary	Time to walk 100 meters	Seconds	2 years
Secondary	Time to walk 100 meters	Seconds	3 years
Secondary	Time to walk 100 meters	Seconds	4 years
Secondary	Time to walk 100 meters	Seconds	5 years
Secondary	Time to walk 100 meters	Seconds	Any relapse (maximum 5 years)
Secondary	2 Minute walking distance	Meters	Inclusion
Secondary	2 Minute walking distance	Meters	6 Months
Secondary	2 Minute walking distance	Meters	1 Year
Secondary	2 Minute walking distance	Meters	2 years
Secondary	2 Minute walking distance	Meters	3 years
Secondary	2 Minute walking distance	Meters	4 years
Secondary	2 Minute walking distance	Meters	5 years
Secondary	2 Minute walking distance	Meters	Any relapse (maximum 5 years)
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	Inclusion
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	6 months
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	1 Year
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	2 years
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	3 years
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	4 years
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	5 years
Secondary	Cognitive Impairment	Symbol Digit Modalities Test	Any relapse (maximum 5 years)
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	Inclusion
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	6 Months
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	1 Year
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	2 years
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	3 years
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	4 years
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	5 years
Secondary	Cognitive evaluation	Brief International Cognitive Assessment for Multiple Sclerosis	Any relapse (maximum 5 years)
Secondary	Health-related quality of life	EQ-5D-5L	Inclusion
Secondary	Health-related quality of life	EQ-5D-5L	6 Months
Secondary	Health-related quality of life	EQ-5D-5L	1 Year
Secondary	Health-related quality of life	EQ-5D-5L	2 years
Secondary	Health-related quality of life	EQ-5D-5L	3 years
Secondary	Health-related quality of life	EQ-5D-5L	4 years
Secondary	Health-related quality of life	EQ-5D-5L	5 years
Secondary	Health-related quality of life	EQ-5D-5L	Any relapse (maximum 5 years)
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	Inclusion
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	6 Months
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	1 Year
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	2 years
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	3 years
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	4 years
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	5 years
Secondary	Impact of MS on daily life	Multiple Sclerosis Impact Scale (MSIS-29)	Any relapse (maximum 5 years)
Secondary	Fatigue	Modified Fatigue Impact Scale	Inclusion
Secondary	Fatigue	Modified Fatigue Impact Scale	6 Months
Secondary	Fatigue	Modified Fatigue Impact Scale	1 Year
Secondary	Fatigue	Modified Fatigue Impact Scale	2 years
Secondary	Fatigue	Modified Fatigue Impact Scale	3 years
Secondary	Fatigue	Modified Fatigue Impact Scale	4 years
Secondary	Fatigue	Modified Fatigue Impact Scale	5 years
Secondary	Fatigue	Modified Fatigue Impact Scale	Any relapse (maximum 5 years)
Secondary	Visual acuity	0= low, 10= good	Inclusion
Secondary	Visual acuity	0= low, 10= good	6 Months
Secondary	Visual acuity	0= low, 10= good	1 Year
Secondary	Visual acuity	0= low, 10= good	2 years
Secondary	Visual acuity	0= low, 10= good	3 years
Secondary	Visual acuity	0= low, 10= good	4 years
Secondary	Visual acuity	0= low, 10= good	5 years
Secondary	Visual acuity	0= low, 10 good	Any relapse (maximum 5 years)
Secondary	Low contrast visual acuity	0= low, 10 good	Inclusion
Secondary	Low contrast visual acuity	0= low, 10 good	6 Months
Secondary	Low contrast visual acuity	0= low, 10 good	1 Year
Secondary	Low contrast visual acuity	0= low, 10 good	2 years
Secondary	Low contrast visual acuity	0= low, 10 good	3 years,
Secondary	Low contrast visual acuity	0= low, 10 good	4 years
Secondary	Low contrast visual acuity	0= low, 10 good	5 years
Secondary	Low contrast visual acuity	0= low, 10 good	Any relapse (maximum 5 years)
Secondary	Relapse description	monofocal, plurifocal	At relapse (maximum 5 years)
Secondary	Number of new lesions	Measured by MRI	At relapse (maximum 5 years)