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Completed

NCT Number: NCT01392872

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuropsychological assessment

Other

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.

Primary outcomes

  1. 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 outcomes

  1. Analysis of variance for repeated measurement

    Time frame: 15 to 30 days before the beginning of treatment, after 36 months

  2. Selective Reminding Test (SRT)

    Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  3. Delayed recall of SRT

    Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  4. Visuo-spatial span

    Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  5. Digit span

    Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  6. Reverse span

    Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  7. Stroop test

    Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  8. • 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

  9. • 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

  10. 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

  11. • 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Dr Remy MORELLO - CHU de Caen
  • University Hospital, Bordeaux
  • University Hospital, Caen
  • University Hospital, Marseille

Registry information

Official study title

Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

Acronym: CoQualSEP

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2011
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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