Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)

Study Overview
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Brief Summary
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Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory. Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).

Official Title
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Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Cognitive evaluation
* Behavioral: Expanded Disability Status Scale (EDSS) score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients : Aged 18-64 years Francophone MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms Having signed an informed consent (later than the day of inclusion and before any examination required by research) Being affiliated to health insurance Controls: Aged 18-64 years Francophone Having signed an informed consent (later than the day of inclusion and before any examination required by research) Being affiliated to health insurance Exclusion Criteria: Patients: Other neurological diseases with impact on cognitive functions. Severe psychiatric disease or severe depression. Current Dependence on alcohol or drugs. Modification or stop of psychotropic treatment in less than a month. Modification of MS treatment in less than a month. Visual, visual-motor and / or motor impairments excluding the ability to perform cognitive tests. Pregnant Controls: Neurologic disease and known chronic systemic with impact on cognitive functions. Severe psychiatric disease or severe depression. Current Dependence on alcohol or drugs. Psychotropic treatment Cognitive complaint Prior cognitive testing with the same tests less than one year. Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms | Behavioral: Cognitive evaluation<br>* Questionnaires for assessment of confounding factors Cognitive evaluation Walking tests and 9 Hole Peg Test<br>Behavioral: Expanded Disability Status Scale (EDSS) score<br>* - EDSS score<br>|
| Experimental: Control<br>healthy subject | Behavioral: Cognitive evaluation<br>* Questionnaires for assessment of confounding factors Cognitive evaluation Walking tests and 9 Hole Peg Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects | average z scores of CEVMT and CSCT | At the inclusion (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education | BCCAMS and MACFIMS | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | 
| Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory | California verbal learning test-II and brief-visual memory test-revised | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | 
| Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R) | congnitive test | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | 
| Prediction between cognitive impairment and occupational status/leisure activities | questionnaire | At the inclusion (Day 0) and 6 months after the inclusion (Day 0) | 
| Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue | scale | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | 
| Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis | congnitive test | At 1 and 6 months after the inclusion (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, brief computerized cognitive assessment, impairment prediction