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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-06-30

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.

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Detailed Description

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Conditions

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Cognitive Disorders Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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procog

cognitive remedial program 13 sessions over a 6-month period

Group Type EXPERIMENTAL

procog

Intervention Type OTHER

3 to 5 people group program

DISINT

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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procog

3 to 5 people group program

Intervention Type OTHER

Placebo

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No