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

Not Applicable

• Conditions: Cognitive Disorders; Multiple Sclerosis
• Interventions: Other: procog; Other: Placebo

• Registration Number: NCT01659593
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Study Start: 2012-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2016-09
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
procog	procog	cognitive remedial program 13 sessions over a 6-month period
DISINT	Placebo	Interactive discussion program of 13 group sessions in a 6-month period

Primary Outcome Measures

Name	Time	Method
cognitive function measured by SRT-List score	0-9 months

Secondary Outcome Measures

Name	Time	Method
quality of life measured by MusiQol	0 -9 months

Trial Locations

Locations (1)

University hospital Nancy; 🇫🇷 Nancy, France