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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03541226

Acronym

cinocis

Enrollment

134

Registered

2018-05-30

Start date

2014-09-30

Completion date

2024-01-31

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically Isolated Syndrome, Multiple Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Occurrence of a second push	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,
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	—

Countries

France

Outcome results