Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant (CoQualSEP)
This study is currently recruiting participants.
Verified July 2011 by University Hospital, Clermont-Ferrand
Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Marseille
Dr Remy MORELLO – CHU de Caen
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01392872
First received: May 5, 2011
Last updated: July 12, 2011
Last verified: July 2011
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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: 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, after 36 months ] [ Designated as safety issue: No ]
- Selective Reminding Test (SRT) [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
- Delayed recall of SRT [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
- Visuo-spatial span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
- Digit span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
- Reverse span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
- Stroop test [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
- • 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 ] [ Designated as safety issue: No ]
- • 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- • 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392872
Contacts
| Contact: Patrick LACARIN | 0473751195 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr | |
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
No publications provided
| Responsible Party: | Patrick LACARIN, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01392872 History of Changes |
| Other Study ID Numbers: | CHU-0094 |
| Study First Received: | May 5, 2011 |
| Last Updated: | July 12, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Immunosuppressant Quality of life Cognitive function Relapsing Multiple Sclerosis |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Stress, Psychological Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Pathologic Processes Behavioral Symptoms Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013