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

Multiple Sclerosis Clinical Trial

— PROCOG-SEP  

Official title:

Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01659593
• Other study ID #: PROCOG-SEP
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2012
• Last updated: March 7, 2016
• Start date: September 2012
• Est. completion date: June 2018

Study information

• Verified date: March 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: National Consultative Ethics Committee for Health and Life SciencesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• procog
3 to 5 people group program
• Placebo

Locations

Country	Name	City	State
France	University hospital Nancy	Nancy

Sponsors (4)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire Dijon, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint		0-9 months	No
Primary	cognitive function measured by SRT-List score		0-9 months	No
Secondary	quality of life measured by MusiQol		0 -9 months	No