Clinical trial NCT01392872: Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant
Official title: Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Immunosuppressant
Quality of life
Cognitive function
Relapsing Multiple Sclerosis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: University Hospital, Caen
name: University Hospital, Marseille
name: Dr Remy MORELLO - CHU de Caen
First posted: 2011-07-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
timeFrame: on a 36 months period
Secondary outcomes:
measure: Analysis of variance for repeated measurement
timeFrame: 15 to 30 days before the beginning of treatment, after 36 months
measure: Selective Reminding Test (SRT)
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
measure: Delayed recall of SRT
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
measure: Visuo-spatial span
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
measure: Digit span
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
measure: Reverse span
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
measure: Stroop test
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
measure: • Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
measure: • Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
measure: Disability (EDSS) : Analysis of variance for repeated measurement
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
measure: • Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement
timeFrame: 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Pierre CLAVELOU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Planche V, Moisset X, Morello R, Dumont E, Gibelin M, Charre-Morin J, Saubusse A, Mondou A, Reuter F, Defer G, Pelletier J, Brochet B, Clavelou P. Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study. J Neurol Sci. 2017 Nov 15;382:148-154. doi: 10.1016/j.jns.2017.10.008. Epub 2017 Oct 6.