Multiple SclerosisBICAFMSNCT02391064
Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS)
A study testing Cognitive evaluation and Expanded Disability Status Scale (EDSS) score in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive evaluation and Expanded Disability Status Scale (EDSS) score
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 15 sitesFrance
- Study dates
- 17 Feb 2015to 18 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU de Bordeaux
Bordeaux, 33000
CHU de Caen
Caen, 14033
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Hôpital du Bocage
Dijon, 21079
CH de Dunkerque
Dunkirk, 59385
Centre Hospitalier Saint Vincent de Paul
Lille, 59020
Hôpital Roger Salengro
Lille
CHU de Marseille
Marseille, 13385
CHU Montpellier
Montpellier, 34295
CHU de Nancy
Nancy, 54035
CHU de Nice
Nice, 06002
Hôpital Tenon
Paris, 75970
Hôpital de Poissy Saint Germain
Poissy, 78303
CHU de Reims
Reims, 51092
CHU de Strasbourg
Strasbourg, 67200
About this study
Official title: Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)
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).
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive evaluation, Expanded Disability Status Scale (EDSS) score
- Keywords
- cognition, brief computerized cognitive assessment, impairment prediction
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive evaluationBehavioural
- Questionnaires for assessment of confounding factors
- Cognitive evaluation
- Walking tests and 9 Hole Peg Test
Expanded Disability Status Scale (EDSS) scoreBehavioural
- EDSS score
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms Receives: Behavioral: Cognitive evaluation; Behavioral: Expanded Disability Status Scale (EDSS) score |
| Control | Experimental | healthy subject Receives: Behavioral: Cognitive evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the inclusion (Day 0)
Secondary outcomes (6)
Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education
BCCAMS and MACFIMS
Measured: 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
California verbal learning test-II and brief-visual memory test-revised
Measured: 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)
congnitive test
Measured: 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
questionnaire
Measured: 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
scale
Measured: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis
congnitive test
Measured: At 1 and 6 months after the inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start17 Feb 2015
- Primary completion18 Feb 2018
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391064
- Sponsor's protocol ID
- CHUBX 2013/23
- Other IDs
- 2014-A01646-41
- Acronym
- BICAFMS
- Status last verified
- Mar 2018
- First submitted
- 18 Feb 2015
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruet A, Brochet B. Cognitive assessment in patients with multiple sclerosis: From neuropsychological batteries to ecological tools. Ann Phys Rehabil Med. 2020 Mar;63(2):154-158. doi: 10.1016/j.rehab.2018.01.006. Epub 2018 Feb 17.
PubMed 29462665Maubeuge N, Deloire MSA, Brochet B, Erhle N, Charre-Morin J, Saubusse A, Ruet A; BICAFMS study investigators. French validation of the Brief International Cognitive Assessment for Multiple Sclerosis. Rev Neurol (Paris). 2021 Jan-Feb;177(1-2):73-79. doi: 10.1016/j.neurol.2020.04.028. Epub 2020 Jul 23.
PubMed 32713736Maubeuge N, Deloire MSA, Brochet B, Ehrle N, Charre-Morin J, Saubusse A, Ruet A; BICAFMS study investigators. Validation of the French version of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). Mult Scler Relat Disord. 2021 Feb;48:102692. doi: 10.1016/j.msard.2020.102692. Epub 2020 Dec 17.
PubMed 33352358Maubeuge N, Deloire MS, Brochet B, Charre-Morin J, Saubusse A, Ruet A. Validation of a Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) and comparison with reference batteries. Mult Scler. 2022 Jun;28(7):1112-1120. doi: 10.1177/13524585211054006. Epub 2021 Nov 12.
PubMed 34766866
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) - BICAFMS Study (Brief Cognitive Assessment in French MS Patients)
- ClinicalTrials.gov ID
- NCT02391064
- Acronym / sponsor ID
- BICAFMS / CHUBX 2013/23
- Conditions
- Multiple Sclerosis
- Keywords
- cognition, brief computerized cognitive assessment, impairment prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 18 Feb 2018 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Behavioral: Cognitive evaluation, Behavioral: Expanded Disability Status Scale (EDSS) scoreMS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms |
| Control | Experimental | Behavioral: Cognitive evaluationhealthy subject |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive evaluation* Questionnaires for assessment of confounding factors * Cognitive evaluation * Walking tests and 9 Hole Peg Test | Behavioural | Control, Patient |
| Expanded Disability Status Scale (EDSS) score- EDSS score | Behavioural | Patient |
Primary outcome
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
6 secondary outcomes
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)
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)
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)
Prediction between cognitive impairment and occupational status/leisure activities
Time frame: 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
Time frame: At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 29462665Ruet A, Brochet B. Cognitive assessment in patients with multiple sclerosis: From neuropsychological batteries to ecological tools. Ann Phys Rehabil Med. 2020 Mar;63(2):154-158. doi: 10.1016/j.rehab.2018.01.006. Epub 2018 Feb 17.
- Results publication: PubMed 32713736Maubeuge N, Deloire MSA, Brochet B, Erhle N, Charre-Morin J, Saubusse A, Ruet A; BICAFMS study investigators. French validation of the Brief International Cognitive Assessment for Multiple Sclerosis. Rev Neurol (Paris). 2021 Jan-Feb;177(1-2):73-79. doi: 10.1016/j.neurol.2020.04.028. Epub 2020 Jul 23.
- Results publication: PubMed 33352358Maubeuge N, Deloire MSA, Brochet B, Ehrle N, Charre-Morin J, Saubusse A, Ruet A; BICAFMS study investigators. Validation of the French version of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). Mult Scler Relat Disord. 2021 Feb;48:102692. doi: 10.1016/j.msard.2020.102692. Epub 2020 Dec 17.
- Results publication: PubMed 34766866Maubeuge N, Deloire MS, Brochet B, Charre-Morin J, Saubusse A, Ruet A. Validation of a Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) and comparison with reference batteries. Mult Scler. 2022 Jun;28(7):1112-1120. doi: 10.1177/13524585211054006. Epub 2021 Nov 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive evaluation and Expanded Disability Status Scale (EDSS) score in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391064, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.