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

University Hospital of Bordeaux

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Cognitive evaluation; Behavioral: Expanded Disability Status Scale (EDSS) score

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02391064

CHUBX 2013/23

Details and patient eligibility

About

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).

Enrollment: 421 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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421 participants in 2 patient groups

Patient

Experimental group

Description:

MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms

Treatment:

Behavioral: Expanded Disability Status Scale (EDSS) score

Behavioral: Cognitive evaluation

Control

Experimental group

Description:

healthy subject

Treatment:

Behavioral: Cognitive evaluation