Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients (PROCOG-SEP)
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|ClinicalTrials.gov Identifier: NCT01659593|
Recruitment Status : Unknown
Verified March 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : August 8, 2012
Last Update Posted : March 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Disorders Multiple Sclerosis||Other: procog Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||June 2018|
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
- cognitive function measured by SRT-List score [ Time Frame: 0-9 months ]
- quality of life measured by MusiQol [ Time Frame: 0 -9 months ]
- cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint [ Time Frame: 0-9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659593
|University hospital Nancy||Recruiting|
|Nancy, France, 54000|
|Contact: Marc DEBOUVERIE, MD 00 33 3 83 15 16 88 email@example.com|
|Principal Investigator: Marc Debouverie, MD,PhD|
|Principal Investigator:||Marc DEBOUVERIE, Professor||CHU NANCY|
|Principal Investigator:||Eric BERGER, MD||CHU de BESANCON|
|Principal Investigator:||Thibaut MOREAU, Professor||Centre Hospitalier Universitaire Dijon|
|Principal Investigator:||Jérôme de Sèze, Professor||CHU de STRASBOURG|