Sclerosis, MultipleXO-SEPNCT03999034
XO as a Screening Test of Cognitive Impairment in Multiple Sclerosis
A study testing questionnaire completion in people with Sclerosis, Multiple and Cognitive Dysfunction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sclerosis, Multiple, Cognitive Dysfunction
- What is being tested?
- questionnaire completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2019to 8 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Healthy controls included must :
- Be men or women aged 18 or more
- Suffer from no pathology that might be incompatible with the study
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Lise LACLAUTRE, +334.73.754.963, drci@chu-clermontferrand.fr
Pierre CLAVELOU
About this study
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.
Read the 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.
- Conditions
- Sclerosis, Multiple, Cognitive Dysfunction
- Being tested
- questionnaire completion
- Keywords
- screening test, XO test
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire completionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | experimental, cognitive test, no treatment investigated. 140 patients (90 relasping remitting and 50 progressive multiple sclerosis) Receives: 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). Receives: Diagnostic Test: questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start8 Jul 2019
- Primary completion8 Sep 2020 (estimated)
- Study completion8 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Every patients and healthy controls will fill in all the tests and questionnaires
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Santé SAS
- Responsible party
- Sponsor
- Investigators
- Pierre CLAVELOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999034
- Sponsor's protocol ID
- RNI 2019 CLAVELOU (XO et SEP)
- Other IDs
- 2019-A00801-56
- Acronym
- XO-SEP
- Status last verified
- Sep 2019
- First submitted
- 24 Jun 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Screening Test of Cognitive Impairment Among Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03999034
- Acronym / sponsor ID
- XO-SEP / RNI 2019 CLAVELOU (XO et SEP)
- Conditions
- Sclerosis, Multiple, Cognitive Dysfunction
- Keywords
- screening test, XO test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Merck Santé SAS
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 8 Sep 2020 (estimated)
- Study completion
- 8 Oct 2020 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Every patients and healthy controls will fill in all the tests and questionnaires
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Diagnostic Test: questionnaire completionexperimental, cognitive test, no treatment investigated. 140 patients (90 relasping remitting and 50 progressive multiple sclerosis) |
| Healthy controls | Experimental | Diagnostic Test: questionnaire completionexperimental, 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire completionEvery 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. | Diagnostic test | Healthy controls, Patients |
Primary outcome
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.
4 secondary outcomes
Score of anxiety
Time frame: Day 0
Score of depression
Time frame: Day 0
Score of asthenia
Time frame: Day 0
Score of pain
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre CLAVELOU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire completion in people with Sclerosis, Multiple and Cognitive Dysfunction, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334.75.754.963, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of XO test (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.