XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis

NCT03999034 | Unknown

• 2 other identifiers: RNI 2019 CLAVELOU (XO et SEP)2019-A00801-56
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Sclerosis, Multiple; Cognitive Dysfunction

Keywords

screening test; XO test

Outcome Measures

Primary Outcomes (1)

• Score of XO test

  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 be also assessed. The percentage of wrong answers doing XO test will be investigated.

  Day 0

Secondary Outcomes (4)

• Score of anxiety

  Day 0

• Score of depression

  Day 0

• Score of asthenia

  Day 0

• Score of pain

  Day 0

Study Arms (2)

Patients

EXPERIMENTAL

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

Diagnostic Test: questionnaire completion

Healthy controls

EXPERIMENTAL

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).

Diagnostic Test: questionnaire completion

Interventions

questionnaire completion 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; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Merck Santé SAS: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pierre CLAVELOU

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.75.754.963; drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Every patients and healthy controls will fill in all the tests and questionnaires

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: July 8, 2019
• Primary Completion: September 8, 2020
• Study Completion: October 8, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

FR (1)