Clinical trial NCT03999034: XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis
Official title: Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sclerosis, Multiple
Cognitive Dysfunction
Keywords: screening test
XO test
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Merck Santé SAS
First posted: 2019-06-26
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Every patients and healthy controls will fill in all the tests and questionnaires
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Score of XO test
timeFrame: Day 0
Secondary outcomes:
measure: Score of anxiety
timeFrame: Day 0
measure: Score of depression
timeFrame: Day 0
measure: Score of asthenia
timeFrame: Day 0
measure: Score of pain
timeFrame: Day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Pierre CLAVELOU
role: PRINCIPAL_INVESTIGATOR
References: