Clinical trial NCT02391064: Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)
Official title: Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: cognition
brief computerized cognitive assessment
impairment prediction
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-03-18
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects
timeFrame: At the inclusion (Day 0)
Secondary outcomes:
measure: Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education
timeFrame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
measure: Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory
timeFrame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
measure: Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R)
timeFrame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
measure: Prediction between cognitive impairment and occupational status/leisure activities
timeFrame: At the inclusion (Day 0) and 6 months after the inclusion (Day 0)
measure: Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue
timeFrame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
measure: Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis
timeFrame: At 1 and 6 months after the inclusion (Day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dijon
country: France
facility: Hôpital du Bocage
city: Dunkerque
country: France
facility: CH de Dunkerque
city: Lille
country: France
facility: Centre Hospitalier Saint Vincent de Paul
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Marseille
country: France
facility: CHU de Marseille
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Tenon
city: Poissy
country: France
facility: Hôpital de Poissy Saint Germain
city: Reims
country: France
facility: CHU de Reims
city: Strasbourg
country: France
facility: CHU de Strasbourg
Study officials:
References: