Cognitive Dysfunction Clinical Trial
Official title:
Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
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.
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.
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