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

This study is currently recruiting participants.
Verified March 2016 by Central Hospital, Nancy, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659593
First Posted: August 8, 2012
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
Information provided by (Responsible Party):
Central Hospital, Nancy, France
  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
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.

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 ]

Secondary Outcome Measures:
  • quality of life measured by MusiQol [ Time Frame: 0 -9 months ]

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 ]

Estimated Enrollment: 140
Study Start Date: September 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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


Locations
France
University hospital Nancy Recruiting
Nancy, France, 54000
Contact: Marc DEBOUVERIE, MD    00 33 3 83 15 16 88    m.debouverie@chu-nancy.fr   
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
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
  More Information

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01659593     History of Changes
Other Study ID Numbers: PROCOG-SEP
First Submitted: August 6, 2012
First Posted: August 8, 2012
Last Update Posted: March 8, 2016
Last Verified: March 2016

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

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