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Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant (CoQualSEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01392872
First Posted: July 13, 2011
Last Update Posted: July 29, 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. Read our disclaimer for details.
Collaborators:
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Marseille
Dr Remy MORELLO – CHU de Caen
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Condition Intervention
Multiple Sclerosis, Relapsing-Remitting Other: Neuropsychological assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant [ Time Frame: on a 36 months period ]

Secondary Outcome Measures:
  • Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, after 36 months ]
  • Selective Reminding Test (SRT) [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ]
  • Delayed recall of SRT [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ]
  • Visuo-spatial span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ]
  • Digit span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ]
  • Reverse span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ]
  • Stroop test [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ]
  • • Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months ]
  • • Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months ]
  • Disability (EDSS) : Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months ]
  • • Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months ]

Enrollment: 48
Study Start Date: November 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sclerosis Other: Neuropsychological assessment
This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Detailed Description:
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Relapsing MS since at least 6 months and less than 10 years
  • Neurological state stable since at least 1 month
  • Moderate Handicap (EDSS ≤ 5,5)

Exclusion Criteria:

  • Secondary Progressive MS
  • Patient having an attack
  • Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month
  • Depressive patient
  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): NCT01392872


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Marseille
Dr Remy MORELLO – CHU de Caen
Investigators
Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01392872     History of Changes
Other Study ID Numbers: CHU-0094
First Submitted: May 5, 2011
First Posted: July 13, 2011
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Immunosuppressant
Quality of life
Cognitive function
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs


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