Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)
BICAFMS
1 other identifier
interventional
421
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Feb 2015
Typical duration for not_applicable multiple-sclerosis
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2015
CompletedFirst Submitted
Initial submission to the registry
February 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2018
CompletedMarch 8, 2018
March 1, 2018
3 years
February 18, 2015
March 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
At the inclusion (Day 0)
Secondary Outcomes (6)
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)
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)
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)
Prediction between cognitive impairment and occupational status/leisure activities
At the inclusion (Day 0) and 6 months after the inclusion (Day 0)
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)
- +1 more secondary outcomes
Study Arms (2)
Patient
EXPERIMENTALMS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms
Control
EXPERIMENTALhealthy subject
Interventions
* Questionnaires for assessment of confounding factors * Cognitive evaluation * Walking tests and 9 Hole Peg Test
Eligibility Criteria
You may qualify if:
- Patients :
- Aged 18-64 years
- Francophone
- Being affiliated to health insurance
- Controls:
- Aged 18-64 years
- Francophone
- Being affiliated to health insurance
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Bayercollaborator
Study Sites (15)
CHU de Bordeaux
Bordeaux, 33000, France
CHU de Caen
Caen, 14033, France
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
Hôpital du Bocage
Dijon, 21079, France
CH de Dunkerque
Dunkirk, 59385, France
Centre Hospitalier Saint Vincent de Paul
Lille, 59020, France
Hôpital Roger Salengro
Lille, France
CHU de Marseille
Marseille, 13385, France
CHU Montpellier
Montpellier, 34295, France
CHU de Nancy
Nancy, 54035, France
CHU de Nice
Nice, 06002, France
Hôpital Tenon
Paris, 75970, France
Hôpital de Poissy Saint Germain
Poissy, 78303, France
CHU de Reims
Reims, 51092, France
CHU de Strasbourg
Strasbourg, 67200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2015
First Posted
March 18, 2015
Study Start
February 17, 2015
Primary Completion
February 18, 2018
Study Completion
February 18, 2018
Last Updated
March 8, 2018
Record last verified: 2018-03