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

NCT04860947 | Active Not Recruiting

• 2 other identifiers: CIVI/2018/ET-012018-A03152-53
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

GFAP; NfL

Outcome Measures

Primary Outcomes (6)

• Change in serum Neurofilament Light Chain serum levels since baseline

  pg/mL; measured by digital ELISA

  Baseline; 1 year

• Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline

  pg/mL; measured by digital ELISA

  Baseline; 1 year

• Change in Ganglion Cell Complex thickness since baseline

  Measured by Optical Coherence Tomography

  Baseline; 1 year

• Change in whole brain volume since baseline

  Assessed by MRI

  Baseline; 1 year

• Expanded Disability Status Scale

  Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)

  Baseline

• 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 Outcomes (165)

• Whole brain volume

  Inclusion

• Whole brain volume

  6 Months

• Whole brain volume

  1 Year

• Whole brain volume

  2 years

• Whole brain volume

  3 Years

Study Arms (1)

MS patients

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

Interventions

Brain MRI DIAGNOSTIC_TEST

* 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.

MS patients

Spinal Cord MRI DIAGNOSTIC_TEST

Sagittal T2 Sagittal T1 with Gadolinium injection

MS patients

Retinal imaging DIAGNOSTIC_TEST

spectral-domain high definition optical coherence tomography

MS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of consecutive adult patients, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of Nîmes University Hospital (CHU). The patients recruited will have an EDSS score comprised between 0 - 7.0.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Institut de Recherches en Biothérapie: collaborator

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric Thouvenot

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 27, 2021
• Study Start: June 25, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

FR (1)