Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant (CoQualSEP)

July 28, 2016 updated by: University Hospital, Clermont-Ferrand

Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Relapsing MS since at least 6 months and less than 10 years
  • Neurological state stable since at least 1 month
  • Moderate Handicap (EDSS ≤ 5,5)

Exclusion Criteria:

  • Secondary Progressive MS
  • Patient having an attack
  • Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month
  • Depressive patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: sclerosis
Other: Neuropsychological assessment
This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
Time Frame: on a 36 months period
on a 36 months period

Secondary Outcome Measures

Outcome Measure
Time Frame
Analysis of variance for repeated measurement
Time Frame: 15 to 30 days before the beginning of treatment, after 36 months
15 to 30 days before the beginning of treatment, after 36 months
Selective Reminding Test (SRT)
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Delayed recall of SRT
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Visuo-spatial span
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Digit span
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Reverse span
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Stroop test
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
• Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
• Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
Disability (EDSS) : Analysis of variance for repeated measurement
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
• Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement
Time Frame: 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months
15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Marseille
Dr Remy MORELLO - CHU de Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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