NCT02887352

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

5.8 years

First QC Date

August 25, 2016

Last Update Submit

June 11, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • CCST Test score

    comparison of the scores of the three versions of the test

    baseline

Interventions

assessment of problem-solving abilityOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

multiple sclerosis patients

You may qualify if:

  • Multiple Sclerosis patients
  • age \> 18 years old

You may not qualify if:

  • Montreal Cognitive Assessment (MOCA) ≤20
  • psychiatric disease
  • no proficiency in the French language
  • opposition to participate in the study
  • no medical insurance coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anne-Claire VIRET

    Fondation OPH A de Rothschild

    STUDY DIRECTOR

  • Olivier GOUT, MD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 2, 2016

Study Start

March 1, 2014

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

FR(1)