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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Other: Neuropsychological assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sclerosis<br> | Other: Neuropsychological assessment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of variance for repeated measurement |  | 15 to 30 days before the beginning of treatment, after 36 months | 
| Selective Reminding Test (SRT) |  | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months | 
| Delayed recall of SRT |  | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months | 
| Visuo-spatial span |  | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months | 
| Digit span |  | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months | 
| Reverse span |  | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months | 
| Stroop test |  | 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 |  | 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 |  | 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 |  | 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 |  | 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunosuppressant, Quality of life, Cognitive function, Relapsing Multiple Sclerosis