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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01659593
• Collaborator: University Hospital, Strasbourg, France (Other), Centre Hospitalier Universitaire Dijon (Other), Centre Hospitalier Universitaire de Besancon (Other)
• Enrollment: 140
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Disorders; Multiple Sclerosis	Other: procog; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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.
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Sep 1, 2016
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: procog cognitive remedial program 13 sessions over a 6-month period	Other: procog; 3 to 5 people group program
Placebo Comparator: DISINT Interactive discussion program of 13 group sessions in a 6-month period	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. cognitive function measured by SRT-List score [0-9 months]

Secondary Outcome Measures

1. quality of life measured by MusiQol [0 -9 months]

Other Outcome Measures

1. cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint [0-9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Nancy	Nancy		France	54000

Sponsors and Collaborators

• Central Hospital, Nancy, France
• University Hospital, Strasbourg, France
• Centre Hospitalier Universitaire Dijon
• Centre Hospitalier Universitaire de Besancon

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT01659593
• Other Study ID Numbers: PROCOG-SEP
• First Posted: Aug 8, 2012
• Last Update Posted: Mar 8, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Central Hospital, Nancy, France: cognitive disorders; multiple sclerosis; neuropsychology
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Cognition Disorders

Study Results

No Results Posted as of Mar 8, 2016