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

Multiple Sclerosis Clinical Trial

— BICAFMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391064
• Other study ID #: CHUBX 2013/23
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: March 7, 2018
• Start date: February 17, 2015
• Est. completion date: February 18, 2018

Study information

• Verified date: March 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Cognitive evaluation
Questionnaires for assessment of confounding factors Cognitive evaluation Walking tests and 9 Hole Peg Test
• Expanded Disability Status Scale (EDSS) score
- EDSS score

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Bayer

Country where clinical trial is conducted

France, 

Outcome

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)