XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis

NCT ID: NCT03999034

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2020-10-08

Brief Summary

Even at the disease onset, about 70% of patients with multiple sclerosis (MS) suffer from cognitive impairment that impacts quality of life. Currently, some speed processing tests are used, such as SDMT ( symbol digit modalities test ), CSCT (information treatment speed evaluation) and WAIS-IV (Weschler Adult Intelligence Scale ). Their inconvenient are the improvement of scores in test-retest, and some difficulties doing the tests due to motor or visual impairment that might be reported. The XO test is fast, cheap and easy to use during medical consult by neurologists. It seems to be correlated to results of speed processing tests, and probably to some executive functions tests too. Asthenia, anxiety, depression and pain are likely to have a negative influence on tests results. Screening every patients with a short test aims to detect patients with cognitive impairment earlier. After a positive screening test, and to better characterize cognitive impairment, they will undergo a neuropsychological test battery. Depending on the alteration, adapted workstation, financial support, technical and human helps will be implemented in order to improve the daily-living of patients.

This study aims to approve the XO as a screening test of cognitive impairment in MS patients. We will study the relationship between XO test, and SDMT, CSCT, WAIS-IV, and also with questionnaires about pain, asthenia (FSS, Fatigue Severity Scale), anxiety and depression (HAD, Hospital Anxiety and Depression ). The XO test will be standardized using a healthy population.

Detailed Description

Even at the disease onset, about 70% of patients with multiple sclerosis (MS) suffer from cognitive impairment that impacts quality of life. Currently, some speed processing tests are used, such as SDMT, CSCT and WAIS-IV. Their inconvenient are the improvement of scores in test-retest, and some difficulties doing the tests due to motor or visual impairment that might be reported. The XO test is fast, cheap and easy to use during medical consult by neurologists. It seems to be correlated to results of speed processing tests, and probably to some executive functions tests too. Asthenia, anxiety, depression and pain are likely to have a negative influence on tests results. Screening every patients with a short test aims to detect patients with cognitive impairment earlier. After a positive screening test, and to better characterize cognitive impairment, they will undergo a neuropsychological test battery. Depending on the alteration, adapted workstation, financial support, technical and human helps will be implemented in order to improve the daily-living of patients.

This study aims to approve the XO as a screening test of cognitive impairment in MS patients. We will study the relationship between XO test, and SDMT, CSCT, WAIS-IV, and also with questionnaires about pain, asthenia (FSS), anxiety and depression (HAD). The XO test will be standardized using a healthy population. 140 multiple sclerosis patients (90 relapsing remitting, and 50 progressive) and 400 healthy controls must be recruited.

Multiple sclerosis patients included must :

• Be men or women aged 18 or more
• Be diagnosed with Multiple Sclerosis (MacDonald criteria, 2017)
• Absence of relapse in the previous month
• Be mother-tongue French, or speaking French fluently
• Be covered by French social security

Healthy controls included must :

• Be men or women aged 18 or more
• Suffer from no pathology that might be incompatible with the study

People who can't be included :

• Patients or controls declining participation to the study, or legally protected, pregnant or breastfeeding women
• Patients suffering from another neurological disease, psychiatric disorder, or developmental abnormalities that were diagnosed before multiple sclerosis
• Patients with cranial trauma, relapse that ended less than 1 month before, or depression in the last 3 months
• Patients with severe motor or visual disabilities There are 4 centers. This is a prospective cohort study, in which data will be collected during a single appointment.

The score obtained doing XO test is the dependent variable that will be compared to the variables due to speed processing and executive functions tests. Test-retest of XO test will also be assessed. The percentage of wrong answers doing XO test will be investigated.

The study is going to last 18 months. Every patient (140) and healthy control (400) will fill in all the tests and questionnaires, except FSS (fatigue severity scale), in a random order during a single appointment. The FSS will be filled in by patients only. All 400 healthy controls will be divided in 20 groups of 20 people, due to gender, age (5 classes: 18-33, 34-43, 44-54, 55-64, and more than 65 years old), and level of education (graduated or not). 60 of them will undergo the XO test at the beginning and again at the end of the appointment to investigate the test-retest effect.

Conditions

Sclerosis, Multiple; Cognitive Dysfunction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients

experimental, cognitive test, no treatment investigated. 140 patients (90 relasping remitting and 50 progressive multiple sclerosis)

Group Type: EXPERIMENTAL

questionnaire completion

Intervention Type: DIAGNOSTIC_TEST

Every patient (140) and healthy control (400) will fill in all the tests and questionnaires, except FSS, in a random order during a single appointment. The FSS will be fill in by patients only. All 400 healthy controls will be divided in 20 groups of 20 people, according to gender, age (5 classes: 18-33, 34-43, 44-54, 55-64, and more than 65 years old), and level of education (graduated or not). 60 of them will pass the XO test at the beginning and again at the end of the consult to investigate the test-retest effect.

Healthy controls

experimental, cognitive test, no treatment investigated. 400 healthy controls divided into 20 groups, due to gender, age (5 classes: 18-33, 34-43, 44-54, 55-64, and more than 65 years old), and level of education (graduated or not).

Group Type: EXPERIMENTAL

questionnaire completion

Intervention Type: DIAGNOSTIC_TEST

Every patient (140) and healthy control (400) will fill in all the tests and questionnaires, except FSS, in a random order during a single appointment. The FSS will be fill in by patients only. All 400 healthy controls will be divided in 20 groups of 20 people, according to gender, age (5 classes: 18-33, 34-43, 44-54, 55-64, and more than 65 years old), and level of education (graduated or not). 60 of them will pass the XO test at the beginning and again at the end of the consult to investigate the test-retest effect.

Interventions

questionnaire completion

Every patient (140) and healthy control (400) will fill in all the tests and questionnaires, except FSS, in a random order during a single appointment. The FSS will be fill in by patients only. All 400 healthy controls will be divided in 20 groups of 20 people, according to gender, age (5 classes: 18-33, 34-43, 44-54, 55-64, and more than 65 years old), and level of education (graduated or not). 60 of them will pass the XO test at the beginning and again at the end of the consult to investigate the test-retest effect.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Multiple sclerosis patients included must :
• Be men or women aged 18 or more
• Be diagnosed Multiple Sclerosis (MacDonald criteria, 2017)
• No relapse in the previous month
• Be mother-tongue French, or speaking French fluently
• Be covered by French social security

Healthy controls included must :

• Be men or women aged 18 or more
• Suffer from no pathology that might be incompatible with the study

Exclusion Criteria

• - Patients or controls declining participation to the study, or legally protected, pregnant or breastfeeding women
• Patients suffering from another neurological disease, psychiatric disorder, or developmental abnormalities that were diagnosed before multiple sclerosis
• Patients with cranial trauma, relapse that ended less than 1 month before, or depression less than 3 months
• Patients with severe motor or visual disabilities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Santé SAS

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre CLAVELOU

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

drci@chu-clermontferrand.fr

+334.75.754.963

Facility Contacts

Lise LACLAUTRE

Role: primary

drci@chu-clermontferrand.fr

+334.73.754.963

Other Identifiers

2019-A00801-56

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2019 CLAVELOU (XO et SEP)

Identifier Type: -

Identifier Source: org_study_id