Informations générales (source: ClinicalTrials.gov)

NCT01659593 Statut inconnu
Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial. (PROCOG-SEP)
Interventional
  • Troubles de la cognition
  • Sclérose en plaques
  • Sclérose
  • Dysfonctionnement cognitif
N/A
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
septembre 2012
juin 2018
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
University hospital Nancy - 54000 - Nancy - France Marc DEBOUVERIE, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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 )


- 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