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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02117375

Acronym

EMISEP

Enrollment

115

Registered

2014-04-17

Start date

2014-01-31

Completion date

2022-07-31

Last updated

2020-06-11

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

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, spinal cord, MRI, longitudinal study, disability

Brief summary

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.

Detailed description

Prospective, multicentric study

Interventions

DEVICEspinal cord MRI follow-up

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

OTHERclinical follow-up

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

OTHERbrain MRI follow-up

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Progressive neurological disability	5 years	Measurement by Expended Disability Status Scale

Secondary

Measure	Time frame	Description
Progressive ambulatory disability	5 years	Measurement by the 25-foot timed-Walked test and 6 minutes walking
Progressive disability in the upper limbs	5 years	Measurement by the nine-hole peg test
Progressive urinary disability	5 years	Measurement by the questionnaire Qualiveen
Progressive difficulty walking	5 years	Measurement by the Multiple Sclerosis Walking Scale 12

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026