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

Multiple Sclerosis Clinical Trial

— EMISEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02117375
• Other study ID #: 2013-A00333-42
• Secondary ID: PHRC/12-07
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2022

Study information

• Verified date: June 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective, multicentric study

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: July 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Device:
• spinal cord MRI follow-up
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio

Other:
• clinical follow-up
Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
• brain MRI follow-up

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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