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出境医 / 临床实验 / XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis (XO-SEP)

XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis (XO-SEP)

Study Description
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.


Condition or disease Intervention/treatment Phase
Sclerosis, Multiple Cognitive Dysfunction Diagnostic Test: questionnaire completion Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Every patients and healthy controls will fill in all the tests and questionnaires
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : September 8, 2020
Estimated Study Completion Date : October 8, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Patients
experimental, cognitive test, no treatment investigated. 140 patients (90 relasping remitting and 50 progressive multiple sclerosis)
Diagnostic Test: 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.

Experimental: 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).
Diagnostic Test: 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.

Outcome Measures
Primary Outcome Measures :
  1. Score of XO test [ Time Frame: Day 0 ]
    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.


Secondary Outcome Measures :
  1. Score of anxiety [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. It is composed of 7 questions ranged from 0 to 3. The test score is ranged from 0 to 21. Higher values are correlated to worse outcome.The score of anxiety is an independent variable that will be compare to score of XO test.

  2. Score of depression [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. It is composed of 7 questions ranged from 0 to 3. The test score is ranged from 0 to 21. Higher values are correlated to worse outcome.The score of depression is an independent variable that will be compare to score of XO test.

  3. Score of asthenia [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the FSS (fatigue severity scale) questionnaire, exploring asthenia in Multiple Sclerosis patients. It is composed of 9 questions ranged from 1 to 7. The test score is ranged from 9 to 63. Higher values are correlated to worse outcome. The score of asthenia is an independent variable that will be compared to score of XO test.

  4. Score of pain [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in a pain questionnaire, exploring both cephalalgia, nociceptive and neuropathic pain. It is composed of 22 questions. Some questions must be answered by "yes" or "no". Some other questions are using a visual analogue pain scale from 0 to 10, where 10 is the worse outcome. Some questions need to write the topography of the pain, and the treatment used. Every answer to the questionnaire of pain is an independent variable that will be compare to score of XO test.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE +334.75.754.963 drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise LACLAUTRE    +334.73.754.963    drci@chu-clermontferrand.fr   
Principal Investigator: Pierre CLAVELOU         
Sub-Investigator: Xavier MOISSET         
Sub-Investigator: Marie IZAUTE         
Sub-Investigator: Delphine CREGUT         
Sub-Investigator: Marion GIBELIN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Merck Santé SAS
Investigators
Layout table for investigator information
Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Score of XO test [ Time Frame: Day 0 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Score of anxiety [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. It is composed of 7 questions ranged from 0 to 3. The test score is ranged from 0 to 21. Higher values are correlated to worse outcome.The score of anxiety is an independent variable that will be compare to score of XO test.
  • Score of depression [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. It is composed of 7 questions ranged from 0 to 3. The test score is ranged from 0 to 21. Higher values are correlated to worse outcome.The score of depression is an independent variable that will be compare to score of XO test.
  • Score of asthenia [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the FSS (fatigue severity scale) questionnaire, exploring asthenia in Multiple Sclerosis patients. It is composed of 9 questions ranged from 1 to 7. The test score is ranged from 9 to 63. Higher values are correlated to worse outcome. The score of asthenia is an independent variable that will be compared to score of XO test.
  • Score of pain [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in a pain questionnaire, exploring both cephalalgia, nociceptive and neuropathic pain. It is composed of 22 questions. Some questions must be answered by "yes" or "no". Some other questions are using a visual analogue pain scale from 0 to 10, where 10 is the worse outcome. Some questions need to write the topography of the pain, and the treatment used. Every answer to the questionnaire of pain is an independent variable that will be compare to score of XO test.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Score of anxiety [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. The score of anxiety is an independent variable that will be compare to score of XO test.
  • Score of depression [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the HAD questionnaire, exploring both anxiety and depression. The score of depression is an independent variable that will be compare to score of XO test.
  • Score of asthenia [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in the FSS questionnaire, exploring both anxiety and depression. The score of asthenia is an independent variable that will be compare to score of XO test.
  • Score of pain [ Time Frame: Day 0 ]
    Every patients and healthy control will fill in a pain questionnaire, exploring both anxiety and depression. The score of pain is an independent variable that will be compare to score of XO test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis
Official Title  ICMJE Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Every patients and healthy controls will fill in all the tests and questionnaires
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sclerosis, Multiple
  • Cognitive Dysfunction
Intervention  ICMJE Diagnostic Test: 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.
Study Arms  ICMJE
  • Experimental: Patients
    experimental, cognitive test, no treatment investigated. 140 patients (90 relasping remitting and 50 progressive multiple sclerosis)
    Intervention: Diagnostic Test: questionnaire completion
  • Experimental: 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).
    Intervention: Diagnostic Test: questionnaire completion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
540
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 8, 2020
Estimated Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lise LACLAUTRE +334.75.754.963 drci@chu-clermontferrand.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999034
Other Study ID Numbers  ICMJE RNI 2019 CLAVELOU (XO et SEP)
2019-A00801-56 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Merck Santé SAS
Investigators  ICMJE
Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP