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

March 7, 2016 updated by: Central Hospital, Nancy, France

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • University Hospital Nancy
        • Contact:
        • Principal Investigator:
          • Marc Debouverie, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive function measured by SRT-List score
Time Frame: 0-9 months
0-9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life measured by MusiQol
Time Frame: 0 -9 months
0 -9 months

Other Outcome Measures

Outcome Measure
Time Frame
cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint
Time Frame: 0-9 months
0-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROCOG-SEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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