Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Other: Neuropsychological assessment
- Registration Number
- NCT01392872
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sclerosis Neuropsychological assessment -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Analysis of variance for repeated measurement 15 to 30 days before the beginning of treatment, after 36 months Reverse span 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 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 Stroop test 15 to 30 days before the beginning of treatment, 1st day of treatment, after 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
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France