Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.|
- cognitive function measured by SRT-List score [ Time Frame: 0-9 months ] [ Designated as safety issue: No ]
- quality of life measured by MusiQol [ Time Frame: 0 -9 months ] [ Designated as safety issue: No ]
- cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint [ Time Frame: 0-9 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
cognitive remedial program 13 sessions over a 6-month period
3 to 5 people group program
Placebo Comparator: DISINT
Interactive discussion program of 13 group sessions in a 6-month period
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659593
|University hospital Nancy||Not yet recruiting|
|Nancy, France, 54000|
|Principal Investigator: Marc Debouverie, MD,PhD|