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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— CoQualSEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392872
• Other study ID #: CHU-0094
• Status: Completed
• Phase: N/A
• First received: May 5, 2011
• Last updated: July 28, 2016
• Start date: November 2009
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Dr Remy MORELLO – CHU de Caen, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant		on a 36 months period	Yes
Secondary	Analysis of variance for repeated measurement		15 to 30 days before the beginning of treatment, after 36 months	No
Secondary	Selective Reminding Test (SRT)		15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months	No
Secondary	Delayed recall of SRT		15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months	No
Secondary	Visuo-spatial span		15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months	No
Secondary	Digit span		15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months	No
Secondary	Reverse span		15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months	No
Secondary	Stroop test		15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months	No
Secondary	• 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	No
Secondary	• 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	No
Secondary	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	No
Secondary	• 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	No