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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Multiple Sclerosis; Cognitive Disorders

Treatments: Other: Placebo; Other: procog

Study type: Interventional

Funder types: Other

Identifiers

NCT01659593

PROCOG-SEP

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

procog

Experimental group

Description:

cognitive remedial program 13 sessions over a 6-month period

Treatment:

Other: procog

DISINT

Placebo Comparator group

Description:

Interactive discussion program of 13 group sessions in a 6-month period

Treatment:

Other: Placebo