Multiple Sclerosis Clinical Trial
— BICAFMSOfficial title:
Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)
Verified date | March 2018 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 421 |
Est. completion date | February 18, 2018 |
Est. primary completion date | February 18, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Bordeaux | |
France | CHU de Caen | Caen | |
France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | Hôpital du Bocage | Dijon | |
France | CH de Dunkerque | Dunkerque | |
France | Centre Hospitalier Saint Vincent de Paul | Lille | |
France | Hôpital Roger Salengro | Lille | |
France | CHU de Marseille | Marseille | |
France | CHU Montpellier | Montpellier | |
France | CHU de Nancy | Nancy | |
France | CHU de Nice | Nice | |
France | Hôpital Tenon | Paris | |
France | Hôpital de Poissy Saint Germain | Poissy | |
France | CHU de Reims | Reims | |
France | CHU de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Bayer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education | BCCAMS and MACFIMS | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | |
Secondary | 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 | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | |
Secondary | Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R) | congnitive test | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | |
Secondary | Prediction between cognitive impairment and occupational status/leisure activities | questionnaire | At the inclusion (Day 0) and 6 months after the inclusion (Day 0) | |
Secondary | Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue | scale | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) | |
Secondary | Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis | congnitive test | At 1 and 6 months after the inclusion (Day 0) |
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