Skip to main content
OpenTrials
Completed

NCT Number: NCT02117375

EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients

The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, France

About this study

Prospective, multicentric study

Who can participate

Healthy volunteers accepted: Yes

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

Patients with multiple sclerosis:

Inclusion criteria

  • Relapsing Remitting Multiple Sclerosis patients (Mac Donald 2010 criteria)
  • First clinical event < 1 year
  • Brain MRI > 9 lesions or/and spinal cord attack with focal lesion on spinal cord MRI
  • Score Expended Disability Status Scale < 3
  • Age between 18 and 40 years

Exclusion criteria

  • Multiple Sclerosis progressive
  • Patients treated with immunosuppressive therapy
  • Pregnancy

Healthy volunteers:

Inclusion criteria

-Age between 18 and 40 years

Exclusion criteria

-Pregnancy

Treatment and study plan

spinal cord MRI follow-up

Device

Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio

Clinical follow-up

Other

Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty

brain MRI follow-up

Other

Primary outcomes

  1. Progressive neurological disability

    Time frame: 5 years

    Measurement by Expended Disability Status Scale

Secondary outcomes

  1. Progressive ambulatory disability

    Time frame: 5 years

    Measurement by the 25-foot timed-Walked test and 6 minutes walking

  2. Progressive disability in the upper limbs

    Time frame: 5 years

    Measurement by the nine-hole peg test

  3. Progressive urinary disability

    Time frame: 5 years

    Measurement by the questionnaire Qualiveen

  4. Progressive difficulty walking

    Time frame: 5 years

    Measurement by the Multiple Sclerosis Walking Scale 12

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: EMISEP

Important dates

Study start
2014
Primary completion
2023
Study completion
2024
First posted
Apr 17, 2014
Registry last updated
Jun 15, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.