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

NCT ID: NCT02391064

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-17

Study Completion Date

2018-02-18

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).

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient

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

Group Type EXPERIMENTAL

Cognitive evaluation

Intervention Type BEHAVIORAL

* Questionnaires for assessment of confounding factors
* Cognitive evaluation
* Walking tests and 9 Hole Peg Test

Expanded Disability Status Scale (EDSS) score

Intervention Type BEHAVIORAL

\- EDSS score

Control

healthy subject

Group Type EXPERIMENTAL

Cognitive evaluation

Intervention Type BEHAVIORAL

* Questionnaires for assessment of confounding factors
* Cognitive evaluation
* Walking tests and 9 Hole Peg Test

Interventions

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Cognitive evaluation

* Questionnaires for assessment of confounding factors
* Cognitive evaluation
* Walking tests and 9 Hole Peg Test

Intervention Type BEHAVIORAL

Expanded Disability Status Scale (EDSS) score

\- EDSS score

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Hôpital du Bocage

Dijon, , France

Site Status

CH de Dunkerque

Dunkirk, , France

Site Status

Centre Hospitalier Saint Vincent de Paul

Lille, , France

Site Status

Hôpital Roger Salengro

Lille, , France

Site Status

CHU de Marseille

Marseille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Hôpital de Poissy Saint Germain

Poissy, , France

Site Status

CHU de Reims

Reims, , France

Site Status

CHU de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2013/23

Identifier Type: -

Identifier Source: org_study_id

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