Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)

CompletedNot a drug-phase studyRelapsing and progressiveNCT02391064

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cognitive evaluation
  • Expanded Disability Status Scale (EDSS) score

What it measured

Main measures

  • 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)

    Thinking and memory

Other measures (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)

    Thinking and memory
  • 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)

    Thinking and memory
  • Prediction between cognitive impairment and occupational status/leisure activities

    At the inclusion (Day 0) and 6 months after the inclusion (Day 0)

    Thinking and memory
  • 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)

    Thinking and memoryFatigueMood and sleep
  • 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)

Who could take part

Relapsing and progressive · 18 to 64

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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History

    1. Started

      Feb 2015

    2. Main results due

      Feb 2018

    3. Finished

      Feb 2018

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