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

Primary Purpose

Sclerosis, Multiple, Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire completion
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sclerosis, Multiple focused on measuring screening test, XO test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Healthy controls

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Score of anxiety
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
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
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
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.

Full Information

First Posted
June 24, 2019
Last Updated
September 30, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Merck Santé SAS
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1. Study Identification

Unique Protocol Identification Number
NCT03999034
Brief Title
XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis
Acronym
XO-SEP
Official Title
Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
September 8, 2020 (Anticipated)
Study Completion Date
October 8, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Merck Santé SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sclerosis, Multiple, Cognitive Dysfunction
Keywords
screening test, XO test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Every patients and healthy controls will fill in all the tests and questionnaires
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
experimental, cognitive test, no treatment investigated. 140 patients (90 relasping remitting and 50 progressive multiple sclerosis)
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
questionnaire completion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score of XO test
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Score of anxiety
Description
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.
Time Frame
Day 0
Title
Score of depression
Description
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.
Time Frame
Day 0
Title
Score of asthenia
Description
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.
Time Frame
Day 0
Title
Score of pain
Description
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+334.75.754.963
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre CLAVELOU
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
+334.73.754.963
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Pierre CLAVELOU
First Name & Middle Initial & Last Name & Degree
Xavier MOISSET
First Name & Middle Initial & Last Name & Degree
Marie IZAUTE
First Name & Middle Initial & Last Name & Degree
Delphine CREGUT
First Name & Middle Initial & Last Name & Degree
Marion GIBELIN

12. IPD Sharing Statement

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XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis

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