Informations générales (source: ClinicalTrials.gov)
Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients (XO-SEP)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
juillet 2019
octobre 2020
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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