Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients

Study Overview
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Brief Summary
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Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities. Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period. Main outcome criteria is evolution of SRT-LIST before and after program.

Official Title
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Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.

Conditions
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Cognitive Disorders, Multiple Sclerosis

Intervention / Treatment
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* Other: procog
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 ≤Aged ≤ 60 at baseline Must be able to understand and read french language Must sign the informed consent form Must be affiliate to French social security multiple sclerosis confirmed by Mac Donald criteria EDSS ≤ 6.0 at baseline Duration of multiple sclerosis ≤ 30 years at baseline mild cognitive disorder ( at least 2 cognitive tasks, at most 5 ) Exclusion Criteria: under legal protection treatment by corticosteroids in the past 4 weeks cognitive remedial program already done neuropsychologic assessment in the past 2 months having an other chronic disease having an other neurologic disease alcohol or drug addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: procog<br>cognitive remedial program 13 sessions over a 6-month period | Other: procog<br>* 3 to 5 people group program<br>|
| Placebo Comparator: DISINT<br>Interactive discussion program of 13 group sessions in a 6-month period | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function measured by SRT-List score |  | 0-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life measured by MusiQol |  | 0 -9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive disorders, multiple sclerosis, neuropsychology