Multiple SclerosisE3C-DIFSEPNCT02887352
French Adaptation of the California Card Sorting Task (CCST) in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- assessment of problem-solving ability
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jan 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: multiple sclerosis patients
Who may be able to join
- Multiple Sclerosis patients
- age > 18 years old
Who cannot join
- Montreal Cognitive Assessment (MOCA) ≤20
- psychiatric disease
- no proficiency in the French language
- opposition to participate in the study
- no medical insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French Adaptation of the CCST (California Card Sorting Task). Comparison of 3 Packages to CCST With Multiple Sclerosis (MS) Patients
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Reims neurological department in collaboration with Rothschild Foundation has developed a French adaptation of CCST. This version includes three cards packages with two alternate forms to control practice effects (test-retest). In order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- assessment of problem-solving ability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of problem-solving abilityOther
What is being measured
The primary outcome is the main question the study is designed to answer.
CCST Test score
comparison of the scores of the three versions of the test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startMar 2014
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Anne-Claire VIRET, Study director, Fondation OPH A de RothschildOlivier GOUT, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887352
- Sponsor's protocol ID
- OGT_2014-1
- Acronym
- E3C-DIFSEP
- Status last verified
- Jun 2021
- First submitted
- 25 Aug 2016
- Last updated
- 14 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Adaptation of the CCST (California Card Sorting Task). Comparison of 3 Packages to CCST With Multiple Sclerosis (MS) Patients
- ClinicalTrials.gov ID
- NCT02887352
- Acronym / sponsor ID
- E3C-DIFSEP / OGT_2014-1
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Reims neurological department in collaboration with Rothschild Foundation has developed a French adaptation of CCST. This version includes three cards packages with two alternate forms to control practice effects (test-retest). In order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in MS patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multiple sclerosis patients
Key inclusion criteria (2 listed)
- Multiple Sclerosis patients
- age > 18 years old
Key exclusion criteria (5 listed)
- Montreal Cognitive Assessment (MOCA) ≤20
- psychiatric disease
- no proficiency in the French language
- opposition to participate in the study
- no medical insurance coverage
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 |
|---|---|---|
| assessment of problem-solving ability | Other | – |
Primary outcome
CCST Test score
Time frame: baseline
comparison of the scores of the three versions of the test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
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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.
Anne-Claire VIRET study director
Fondation OPH A de Rothschild
Olivier GOUT, MD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCST Test score (time frame: baseline). 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 14 Jun 2021.