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OpenTrials
Completed

NCT Number: NCT03541226

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

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.

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Key information

Conditions

Clinically Isolated Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0

    Time frame: At 5 years

Secondary outcomes

  1. Occurrence of a second push

    Time frame: At 5 years

  2. Occurrence of progression of the EDSS (Expanded Disability Status Scale) score

    Time frame: 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,

  3. Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC)

    Time frame: At 5 years

  4. variation of parameters measuring axonal pain / degeneration in MRI

    Time frame: At 5 years

  5. variation of parameters measuring axonal pain / degeneration in OCT

    Time frame: At 5 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: cinocis

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
May 30, 2018
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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