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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive evaluation
Expanded Disability Status Scale (EDSS) score
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring cognition, brief computerized cognitive assessment, impairment prediction

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • CHU de Bordeaux
  • CHU de Caen
  • CHU de Clermont-Ferrand
  • Hôpital du Bocage
  • CH de Dunkerque
  • Centre Hospitalier Saint Vincent de Paul
  • Hôpital Roger Salengro
  • CHU de Marseille
  • CHU Montpellier
  • CHU de Nancy
  • CHU de Nice
  • Hôpital Tenon
  • Hôpital de Poissy Saint Germain
  • CHU de Reims
  • CHU de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Control

Arm Description

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

healthy subject

Outcomes

Primary Outcome Measures

Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects
average z scores of CEVMT and CSCT

Secondary Outcome Measures

Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education
BCCAMS and MACFIMS
Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory
California verbal learning test-II and brief-visual memory test-revised
Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R)
congnitive test
Prediction between cognitive impairment and occupational status/leisure activities
questionnaire
Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue
scale
Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis
congnitive test

Full Information

First Posted
February 18, 2015
Last Updated
March 7, 2018
Sponsor
University Hospital, Bordeaux
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02391064
Brief Title
Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)
Acronym
BICAFMS
Official Title
Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 17, 2015 (Actual)
Primary Completion Date
February 18, 2018 (Actual)
Study Completion Date
February 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
cognition, brief computerized cognitive assessment, impairment prediction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Arm Title
Control
Arm Type
Experimental
Arm Description
healthy subject
Intervention Type
Behavioral
Intervention Name(s)
Cognitive evaluation
Intervention Description
Questionnaires for assessment of confounding factors Cognitive evaluation Walking tests and 9 Hole Peg Test
Intervention Type
Behavioral
Intervention Name(s)
Expanded Disability Status Scale (EDSS) score
Intervention Description
- EDSS score
Primary Outcome Measure Information:
Title
Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects
Description
average z scores of CEVMT and CSCT
Time Frame
At the inclusion (Day 0)
Secondary Outcome Measure Information:
Title
Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education
Description
BCCAMS and MACFIMS
Time Frame
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Title
Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory
Description
California verbal learning test-II and brief-visual memory test-revised
Time Frame
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Title
Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R)
Description
congnitive test
Time Frame
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Title
Prediction between cognitive impairment and occupational status/leisure activities
Description
questionnaire
Time Frame
At the inclusion (Day 0) and 6 months after the inclusion (Day 0)
Title
Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue
Description
scale
Time Frame
At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Title
Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis
Description
congnitive test
Time Frame
At 1 and 6 months after the inclusion (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CH de Dunkerque
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
Centre Hospitalier Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
Country
France
Facility Name
CHU de Marseille
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hôpital de Poissy Saint Germain
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
CHU de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France

12. IPD Sharing Statement

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

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