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Clinical Trials/NCT01659593
NCT01659593
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Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.

Central Hospital, Nancy, France1 site in 1 country140 target enrollmentSeptember 2012
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ConditionsCognitive DisordersMultiple Sclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Disorders
Sponsor
Central Hospital, Nancy, France
Enrollment
140
Locations
1
Primary Endpoint
cognitive function measured by SRT-List score
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
June 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

cognitive function measured by SRT-List score

Time Frame: 0-9 months

Secondary Outcomes

  • quality of life measured by MusiQol(0 -9 months)

Study Sites (1)

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