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

• Conditions: Clinically Isolated Syndrome; Multiple Sclerosis

• Registration Number: NCT03541226
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0	At 5 years

Secondary Outcome Measures

Name	Time	Method
Occurrence of a second push	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
Occurrence of progression of the EDSS (Expanded Disability Status Scale) score	At 5 years	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,

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHRU de Lille; 🇫🇷 Lille, France