Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Reverse span(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)
- Analysis of variance for repeated measurement(15 to 30 days before the beginning of treatment, after 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)
- 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)
- 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)
- • 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)
- • 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)
- Stroop test(15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months)