Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 421
- Locations
- 29
- Primary Endpoint
- Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
- •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.
- •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.
Arms & Interventions
Patient
MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Intervention: Cognitive evaluation (Behavioral)
Patient
MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Intervention: Expanded Disability Status Scale (EDSS) score (Behavioral)
Control
healthy subject
Intervention: Cognitive evaluation (Behavioral)
Outcomes
Primary Outcomes
Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects
Time Frame: At the inclusion (Day 0)
average z scores of CEVMT and CSCT
Secondary Outcomes
- Prediction between cognitive impairment and occupational status/leisure activities(At the inclusion (Day 0) 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(At 1 and 6 months after the inclusion (Day 0))
- Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education(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)(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(At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0))
- Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue(At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0))