Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome (CIS) (cinocis)

Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome

The purpose of this study is to develop tools to detect, measure, monitor and predict axonal damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to consider as early as possible an adaptation of the background treatment in patients with MS. patients with radiological criteria of poor long-term clinical course.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hopital Roger Salengro, CHRU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient with clinically isolated syndrome (CIS)

Description

Inclusion Criteria:

• Any patient who has had a CIS of less than 4 months (+/- 15 days), with at least 1 inflammatory lesion on his initial brain MRI or with normal brain MRI associated with the presence of oligoclonal bands in the CSF,

Exclusion Criteria:

• Atypical CIS for a first relapse of multiple sclerosis (extensive myelitis, bilateral retrobulbar optic neuritis immediately)
• CIS dating more than 4 months (+/- 15 days)
• Corticotherapy in the last 4 weeks

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0	At 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a second push		At 5 years
Occurrence of progression of the EDSS (Expanded Disability Status Scale) score	The scale evaluated the pyramidal, cerebellar, sensory, visual and mental functions . These make it possible to obtain a quotation between 0 and 10. The walk is called "normal" from 0 to 3.5. The walk is hampered from 4 and impossible from 7.5. The coast of 10 corresponds to the death of the patient. This measure differentiates two groups: severe EDSS and non-severe EDSS group,	At 5 years
Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC)		At 5 years
variation of parameters measuring axonal pain / degeneration in MRI		At 5 years
variation of parameters measuring axonal pain / degeneration in OCT		At 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Olivier Outteryck, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: 2012_56; 2013-A00475-40 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No