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

This study is not yet open for participant recruitment.
Verified August 2012 by Central Hospital, Nancy, France
Sponsor:
Collaborators:
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01659593
First received: August 6, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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 Intervention
Cognitive Disorders
Multiple Sclerosis
Other: procog
Other: Placebo

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • cognitive function measured by SRT-List score [ Time Frame: 0-9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life measured by MusiQol [ Time Frame: 0 -9 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 ≤Aged ≤ 50 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 ≤ 5.0 at baseline
  • Duration of multiple sclerosis ≤ 20 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 3 months
  • having an other chronic disease
  • having an other neurologic disease
  • alcohol or drug addiction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659593

Locations
France
University hospital Nancy Not yet recruiting
Nancy, France, 54000
Principal Investigator: Marc Debouverie, MD,PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01659593     History of Changes
Other Study ID Numbers: PROCOG-SEP
Study First Received: August 6, 2012
Last Updated: August 30, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: National Consultative Ethics Committee for Health and Life Sciences
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Central Hospital, Nancy, France:
cognitive disorders
multiple sclerosis
neuropsychology

Additional relevant MeSH terms:
Cognition Disorders
Multiple Sclerosis
Sclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014