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Completed

NCT Number: NCT02391064

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive evaluation

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

Expanded Disability Status Scale (EDSS) score

Behavioral
  • EDSS score

Primary outcomes

  1. Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects

    Time frame: At the inclusion (Day 0)

    average z scores of CEVMT and CSCT

Secondary outcomes

  1. Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education

    Time frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)

    BCCAMS and MACFIMS

  2. Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory

    Time frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)

    California verbal learning test-II and brief-visual memory test-revised

  3. Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R)

    Time frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)

    congnitive test

  4. Prediction between cognitive impairment and occupational status/leisure activities

    Time frame: At the inclusion (Day 0) and 6 months after the inclusion (Day 0)

    questionnaire

  5. Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue

    Time frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)

    scale

  6. Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis

    Time frame: At 1 and 6 months after the inclusion (Day 0)

    congnitive test

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Acronym: BICAFMS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2015
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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