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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Cognitive evaluation; Behavioral: Expanded Disability Status Scale (EDSS) score

• Registration Number: NCT02391064
• Lead Sponsor: University Hospital, Bordeaux

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-17
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Primary Completion: 2018-02-18
• Study Completion: 2018-02-18
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient	Cognitive evaluation	MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Patient	Expanded Disability Status Scale (EDSS) score	MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Control	Cognitive evaluation	healthy subject

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prediction between cognitive impairment and occupational status/leisure activities	At the inclusion (Day 0) and 6 months after the inclusion (Day 0)	questionnaire
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)	congnitive test
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)	BCCAMS and MACFIMS
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)	congnitive test
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)	California verbal learning test-II and brief-visual memory test-revised
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)	scale

Trial Locations

Locations (15)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Saint Vincent de Paul; 🇫🇷 Lille, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Nice; 🇫🇷 Nice, France

CHU de Caen; 🇫🇷 Caen, France

Hôpital du Bocage; 🇫🇷 Dijon, France

Hôpital Tenon; 🇫🇷 Paris, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Marseille; 🇫🇷 Marseille, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU de Reims; 🇫🇷 Reims, France

Hôpital de Poissy Saint Germain; 🇫🇷 Poissy, France

CH de Dunkerque; 🇫🇷 Dunkerque, France